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Findings | In this pragmatic randomized clinical trial including 287 patients at 19 sites in 3 countries, the rate unfavorable neurologic outcome was 32.6% in the lumbar drainage group (47 of 144) and 44.8% in the standard of care group (64 of 143), a significant difference. | PMC10277935 | ||
Meaning | aneurysmal subarachnoid hemorrhage, lumbar cerebrospinal fluid | In this trial, among patients with aneurysmal subarachnoid hemorrhage, lumbar drainage improved clinical neurological outcomes at 6 months.This pragmatic randomized clinical trial evaluates the effectiveness of early lumbar cerebrospinal fluid drainage added to standard of care in patients after aneurysmal subarachnoid hemorrhage. | PMC10277935 | |
Importance | aneurysmal subarachnoid hemorrhage | DELAYED CEREBRAL ISCHEMIA | After aneurysmal subarachnoid hemorrhage, the use of lumbar drains has been suggested to decrease the incidence of delayed cerebral ischemia and improve long-term outcome. | PMC10277935 |
Objective | lumbar cerebrospinal fluid, aneurysmal subarachnoid hemorrhage | To determine the effectiveness of early lumbar cerebrospinal fluid drainage added to standard of care in patients after aneurysmal subarachnoid hemorrhage. | PMC10277935 | |
Design, Setting, and Participants | acute aneurysmal subarachnoid hemorrhage, Aneurysm | ANEURYSM | The EARLYDRAIN trial was a pragmatic, multicenter, parallel-group, open-label randomized clinical trial with blinded end point evaluation conducted at 19 centers in Germany, Switzerland, and Canada. The first patient entered January 31, 2011, and the last on January 24, 2016, after 307 randomizations. Follow-up was completed July 2016. Query and retrieval of data on missing items in the case report forms was completed in September 2020. A total of 20 randomizations were invalid, the main reason being lack of informed consent. No participants meeting all inclusion and exclusion criteria were excluded from the intention-to-treat analysis. Exclusion of patients was only performed in per-protocol sensitivity analysis. A total of 287 adult patients with acute aneurysmal subarachnoid hemorrhage of all clinical grades were analyzable. Aneurysm treatment with clipping or coiling was performed within 48 hours. | PMC10277935 |
Intervention | Early lumbar drainage, aneurysm | SUBARACHNOID HEMORRHAGE, ANEURYSM | A total of 144 patients were randomized to receive an additional lumbar drain after aneurysm treatment and 143 patients to standard of care only. Early lumbar drainage with 5 mL per hour was started within 72 hours of the subarachnoid hemorrhage. | PMC10277935 |
Main Outcomes and Measures | hemorrhage | HEMORRHAGE | Primary outcome was the rate of unfavorable outcome, defined as modified Rankin Scale score of 3 to 6 (range, 0 to 6), obtained by masked assessors 6 months after hemorrhage. | PMC10277935 |
Results | aneurysmal subarachnoid hemorrhage | Of 287 included patients, 197 (68.6%) were female, and the median (IQR) age was 55 (48-63) years. Lumbar drainage started at a median (IQR) of day 2 (1-2) after aneurysmal subarachnoid hemorrhage. At 6 months, 47 patients (32.6%) in the lumbar drain group and 64 patients (44.8%) in the standard of care group had an unfavorable neurological outcome (risk ratio, 0.73; 95% CI, 0.52 to 0.98; absolute risk difference, −0.12; 95% CI, −0.23 to −0.01; | PMC10277935 | |
Conclusion and Relevance | aneurysmal subarachnoid hemorrhage, infarction | SECONDARY, INFARCTION | In this trial, prophylactic lumbar drainage after aneurysmal subarachnoid hemorrhage lessened the burden of secondary infarction and decreased the rate of unfavorable outcome at 6 months. These findings support the use of lumbar drains after aneurysmal subarachnoid hemorrhage. | PMC10277935 |
Trial Registration | ClinicalTrials.gov Identifier: | PMC10277935 | ||
Introduction | death, intracranial aneurysm, a ruptured cerebral aneurysm, stroke, Subarachnoid hemorrhage, permanent disability, hemorrhage, rupture, culprit aneurysm | INTRACRANIAL ANEURYSM, STROKE, SUBARACHNOID HEMORRHAGE, HEMORRHAGE, SUBARACHNOID HEMORRHAGE, RUPTURED CEREBRAL ANEURYSM | Subarachnoid hemorrhage from the rupture of an intracranial aneurysm is a type of stroke leading to death or permanent disability in most affected patients.It is common standard to occlude the culprit aneurysm by surgical clipping or endovascular coiling within 24 to 48 hours after hemorrhage, with coiling being preferred if both methods are equally feasible.We designed the EARLYDRAIN trial to investigate the effect of a lumbar cerebrospinal fluid drainage among patients with a ruptured cerebral aneurysm. Our hypothesis was that early application of a lumbar drain leads to an improved outcome after subarachnoid hemorrhage, measured by the modified Rankin Scale (mRS) score at 6 months. | PMC10277935 |
Methods | PMC10277935 | |||
Trial Design and Oversight | subarachnoid hemorrhage, aneurysm | SUBARACHNOID HEMORRHAGE, ANEURYSM | The EARLYDRAIN trial was a pragmatic, multicenter, parallel-group, open-label randomized clinical trial with blinded end point evaluation performed in 19 hospitals in Germany, Switzerland, and Canada. Trial sites were referral centers that provided acute neurosurgical and neurocritical care for patients with subarachnoid hemorrhage on a 24-hour basis with at least 30 aneurysm procedures per year. The protocol included a statistical analysis proposal and was published at the start of the trial,Lead ethics approval was obtained from the research Ethics Committee of the University of Erlangen, Germany. The trial was approved locally from the corresponding ethics board at each participating center. If possible, written informed consent was obtained from the patient before the aneurysm treatment procedure. In patients unable to consent, a legally authorized representative was asked for permission. If this person required court approval not available in due time, a physician not involved in the EARLYDRAIN trial was allowed to consent as a surrogate on the presumed will of a capable person, according to German law. Later stepwise approval by the designated person and finally the patient themselves was obtained. In Switzerland and Canada, approval for study inclusion was granted by the next of kin, as required by local laws. | PMC10277935 |
Participants | intracranial aneurysm, aneurysmal, Aneurysm, hemorrhage, acute subarachnoid hemorrhage | ANEURYSM, HEMORRHAGE, SUBARACHNOID HEMORRHAGE, INTRACRANIAL ANEURYSM | To be eligible, patients had to be 18 years or older and present with acute subarachnoid hemorrhage diagnosed by computed tomography (CT) and confirmation of an intracranial aneurysm by CT angiography or digital subtraction angiography. Aneurysm treatment was required to be performed within 48 hours after subarachnoid hemorrhage. Exclusion criteria included contraindications for placement of a lumbar drain, notably absent or compressed basal cisterns on admission CT or the presence of therapeutic anticoagulation, pregnancy, participation in another interventional trial, reduced life expectancy, and hemorrhage of other than aneurysmal origin (eTable 1 in | PMC10277935 |
Randomization | Eligible patients were randomized in a 1:1 ratio to receive either standard of care or the additional use of a lumbar drain. Randomization was performed via an internet randomizer. | PMC10277935 | ||
Data Collection | death | RECRUITMENT | Patients included in the EARLYDRAIN trial were followed up to their death or 6 months after randomization. Primary documentation was paper based and entered centrally in a database after finishing the recruitment phase. We collected baseline demographic and processes-of-care data from the first 8 days, descriptive radiologic imaging, and 6 months’ outcome. | PMC10277935 |
Trial Procedures | vasospasm, aneurysm, angioplasty | ANEURYSM, VASOSPASM, STERILE, SUBARACHNOID HEMORRHAGE, EMERGENCY | Emergency treatment on admission using intubation and/or placement of an external ventricular drain was at the discretion of the local team. We performed aneurysm treatment with coiling or clipping, as applicable and per local standard and in concordance with international guidelines and recommendations.In case of randomization to the lumbar drain group, a lumbar drain was placed in sterile technique after aneurysm treatment. Lumbar cerebrospinal fluid diversion was started after a postprocedural CT scan indicated safety. A rate of 5 mL per hour was recommended for the first 8 days. Protocol-compliant treatment required at least 4 days, resulting in an equivalent of 480 mL of lumbar cerebrospinal fluid drainage for per-protocol analysis. Additional diversion via external ventricular drainage was at the discretion of the local team. Intracranial pressure (ICP) monitoring was performed as per local standard. Zeroing of both ventricular and lumbar drains was similar on the level of the external acoustic channel. This facilitated a valid ICP reading of all drains and allowed to recognize a developing craniocaudal gradient as indication for excess lumbar drainage.Daily transcranial Doppler monitoring was performed as per local standard. In case of suspected vasospasm or routinely on day 7 to 10 after the initial subarachnoid hemorrhage, vascular imaging either via CT angiography, magnetic resonance angiography, or conventional digital subtraction angiography was scheduled. Treatment of confirmed vasospasm could include balloon angioplasty or local intra-arterial vasodilators, with application being at the discretion of the local investigators and not specified in the EARLYDRAIN trial protocol. Due to the interventional character of the trial, blinding of acute caregivers, except local radiologists, was not possible. | PMC10277935 |
Primary and Secondary End Points | subarachnoid hemorrhage, aneurysm, infarctions | SUBARACHNOID HEMORRHAGE, ANEURYSM, SECONDARY | Primary end point was the rate of unfavorable neurological outcome at 6 months after subarachnoid hemorrhage measured with the mRS.The main secondary end point was the rate of secondary infarctions not being present in the postprocedural CT scan performed after aneurysm occlusion. Secondary infarctions were diagnosed with the last cerebral imaging (either CT or magnetic resonance imaging) before discharge from acute care. Radiologists evaluating the scans received no information on treatment groups. Further secondary end points included the rate of mortality in both groups; the Barthel score | PMC10277935 |
Statistical Analysis | REGRESSION, SECONDARY | For sample size calculation in the study planning phase, available retrospective studies were of questionable external validity due to their exceptionally low mortality. Data from the prospective LUMAS trial were not yet available.All statistics were performed with R version 4.1.0 (The R Foundation). Missing data were not imputed. Group differences of categorical variables were tested with the χIntention-to-treat analysis included all patients meeting all inclusion criteria and without exclusion criteria, regardless of their actual treatment. We performed additional sensitivity analysis in patients treated per protocol and as treated. Per-protocol analysis included all patients in the lumbar drain group with 480 mL or more drainage via lumbar route in the first 8 days and all patients in the standard of care group without a lumbar drain or, in case this was violated, receiving less than 480 mL of lumbar drainage in the first 8 days. The as-treated analysis was performed using all data according to the actual treatment, considering the patients being excluded in the per-protocol analysis in the corresponding other group.We used logistic regression for analysis of primary and secondary end points to allow for easy expansion to multivariate assessment. Odds ratios were transformed to risk ratios for more appropriate interpretation.Adjustment for multiple testing was not performed. Therefore, we regard all analysis beyond the primary end point as exploratory. Significance tests on secondary end points and other variables are provided to illuminate potential signals in the data and not for causal inference. A 2-sided | PMC10277935 | |
Results | PMC10277935 | |||
Patient Characteristics | RECRUITMENT | The first patient was enrolled January 31, 2011. After 300 randomizations, 7 allocation failures were known, and the data monitoring and safety board decided to replace these. On January 24, 2016, recruitment in the EARLYDRAIN trial finished after 307 randomizations. A total of 152 randomizations indicated standard of care treatment and 155 were referred to additional placement of a lumbar drain. Eleven randomizations in the lumbar drain group and 9 in the standard of care group lacked complete inclusion criteria or had an exclusion criterion emerging. Main reasons for invalid randomizations were lack of or withdrawn informed consent and a requirement of high-grade therapeutic anticoagulation unforeseeable at the time of randomization. ( | PMC10277935 | |
CONSORT Diagram | Patients were screened by acute care clinicians from the affiliated centers, mainly the departments of neurology and neurosurgery. Numbers of screened patients were not recorded in all affiliated hospitals (eTable 2 in Of 287 included patients, 197 (68.6%) were female, and the median (IQR) age was 55 (48-63) years. A total of 287 randomized patients were analyzed according to the intention-to-treat principle, with 144 in the lumbar drain group and 143 in the standard of care group ( | PMC10277935 | ||
Baseline Characteristics of Patients Recruited for the EARLYDRAIN trial (Intention-To-Treat Data) | aneurysm, fever, Aneurysm, vasospasm, subarachnoid hemorrhage | ANEURYSM, SUBARACHNOID HEMORRHAGE, VASOSPASM, ANEURYSM | Abbreviations: ACA, anterior cerebral artery; ACoA, anterior communicating artery; BA, basilar artery; ICA, internal carotid artery; MCA, middle cerebral artery; PCoA, posterior communicating artery; VA, vertebral artery; WFNS, World Federations of Neurosurgical Societies.Hunt-Hess and WFNS (World Federations of Neurosurgical Societies) scales are severity gradings scales, with 1 indicating the least severe and 5 indicating the worst neurological status on admission.The modified Fisher classification is a radiological grading scale of subarachnoid hemorrhage severity ranging from 1 to 4, with higher scores indicating more severity.Aneurysm size not available in 8 patients.In the lumbar drain group, 109 patients (75.7%) received a lumbar drain after aneurysm treatment with drainage as specified. A total of 141 patients (98.6%) in the standard of care group were treated according to protocol; 2 (1.4%) received high-volume lumbar drainage as specified for the lumbar drain group. All crossover patients were kept in the intention-to-treat analysis in their randomized groups, independent of actual treatment. This results in a conservative estimation of effect size. Patients from both groups with drainage as specified were looked at in the per-protocol sensitivity analysis, while actual treatment was investigated in the as-treated analysis, with a threshold of 480-mL lumbar drainage in the first 8 days to separate between groups. Reasons for crossover from both groups, as far as known, can be found in eAppendix 1 in Patients in the lumbar drain group received a median (IQR) daily lumbar drainage of 108 (92-118) mL in the first 8 days. A total of 102 patients (70.8%) in the lumbar drain group and 110 patients (76.9%) in the standard of care group had an external ventricular drain installed. Median (IQR) daily fluid drainage via ventricular drain was lower in the lumbar drain group (98 [60-150] mL vs 171 [110-225] mL; Patients in the lumbar drain group showed a lower ICP. No differences were noted in mean daily arterial pressure, fever burden, transcranial Doppler, hemoglobin levels, fluid intake, and fluid balance (eFigures 3-13 in No differences between the lumbar drain group and standard of care group were observed in the frequency of vasospasm diagnosed clinically (41 [28.5%] vs 48 [33.6%]; | PMC10277935 |
Analysis of Primary and Secondary Outcomes | death, aneurysm occlusion | INTRAVENTRICULAR HEMORRHAGE | Abbreviations: GOS-E, Glasgow Outcome Scale–Extended; mRS, modified Rankin Scale score; NA, not applicable; VP, ventriculoperitoneal.Adjustment for baseline imbalances performed with the parameters of age, Hunt-Hess grade greater than 3, and intracerebral or intraventricular hemorrhage.No transcranial Doppler was performed in 28 patients.No angiography was performed after aneurysm occlusion in 65 patients due to early death or local standard operating procedure.Analysis performed for surviving patients. Barthel Index at 6 months value missing in 2 patients. | PMC10277935 |
Primary End Point | No patient was lost for evaluation of the primary end point. In the intention-to-treat analysis, 47 of 144 patients (32.6%) in the lumbar drain group and 64 of 143 patients (44.8%) in the standard of care group had an unfavorable outcome at 6 months (unadjusted relative risk, 0.73; 95% CI, 0.51-0.98; absolute risk difference, −0.12; 95% CI, 0.23 to 0.01; | PMC10277935 | ||
Scores on the Modified Rankin Scale (mRS) at 6 Months, Intention-to-Treat Data | subarachnoid hemorrhage, death, disability | MINOR, SUBARACHNOID HEMORRHAGE | Patients in the lumbar drain group received standard of care and additional lumbar drain at a planned rate of 5-mL lumbar cerebrospinal fluid diversion in the first 8 days. Patients in the standard of care group received standard of care subarachnoid hemorrhage treatment alone. Scores on the mRS range from 0 to 6, with 0 indicating no symptoms; 1, no clinically significant disability; 2, minor functional impairment; 3, moderate disability with preserved ability to walk; 4, moderate severe functional impairment without ability to walk without assistance; 5, severe functional impairment requiring constant care; and 6, death. | PMC10277935 |
Secondary End Points | infarction | SECONDARY, INFARCTION | A total of 41 patients (28.5%) in the lumbar drain group and 57 patients (39.9%) in the standard of care group experienced a secondary infarction seen on the last cerebral imaging scan before discharge (unadjusted relative risk, 0.71; 95% CI, 0.49-0.99; absolute risk difference, −0.11; 95% CI, −0.22 to 0; | PMC10277935 |
Subgroup Analysis | The effect of lumbar drains on the primary outcome was consistent across prespecified subgroups ( | PMC10277935 | ||
Subgroup Analysis | death, subarachnoid hemorrhage, high-grade functional disability | SUBARACHNOID HEMORRHAGE | The forest plot shows that the relative risk of moderate-grade to high-grade functional disability or death favors treatment with a lumbar drain additional to standard of care across all prespecified subgroups. Hunt-Hess and World Federations of Neurosurgical Societies (WFNS) scales are severity gradings scales, with 1 indicating the least severe and 5 indicating the worst neurological status on admission. The modified Fisher classification is a radiological grading scale of subarachnoid hemorrhage severity ranging from 1 to 4, with higher scores indicating more severity. EVD indicates external ventricular drain; mRS, modified Rankin Scale. | PMC10277935 |
Per-Protocol and As-Treated Sensitivity Analysis | infarctions | INTRAVENTRICULAR HEMORRHAGE | End points for sensitivity analysis were the rate of infarctions at discharge and long-term unfavorable outcome. Analyses were performed unadjusted and adjusted for baseline imbalances in age, Hunt-Hess grade, and intraparenchymal and intraventricular hemorrhages. All outcomes in sensitivity analyses were in favor of the lumbar drain group ( | PMC10277935 |
Adverse Events | infections, skin infection | INFECTIONS, SKIN INFECTION | One patient was reported to develop an increasing gradient of more than 5 mm Hg in ICP readings from the external ventricular drain and the lumbar drain, prohibiting continuation of lumbar drainage. One patient developed a local skin infection at the entrance of the lumbar drain requiring surgical excision. In 1 patient, the lumbar drain was torn off, requiring surgical removal. No difference was noted for the rate of suspected infections ( | PMC10277935 |
Post Hoc Analysis | Infarctions, infarctions, Vasospasm | INFARCTIONS, VASOSPASM | Vasospasm, detected by clinical means, transcranial Doppler, or with angiography, was associated with the rate of infarctions at discharge. Infarctions at discharge were associated with unfavorable outcome at 6 months (eTables 4-9 in | PMC10277935 |
Discussion | pneumonia, fever, traumatic brain injury, brain edema, obstructive hydrocephalus, vasospasm, infarctions, Infarct, aneurysmal subarachnoid hemorrhage, Vasospasm | DELAYED CEREBRAL ISCHEMIA, PNEUMONIA, BRAIN EDEMA, OBSTRUCTIVE HYDROCEPHALUS, DEPOLARIZATION, CNS INFECTIONS, VASOSPASM, DISEASE, SECONDARY, INFARCT, VASOSPASM | In the EARLYDRAIN trial involving patients with aneurysmal subarachnoid hemorrhage of all grades, the use of a lumbar drain in addition to standard of care resulted in less infarctions at discharge and decreased the rate of unfavorable outcome at 6 months. The amount of cerebrospinal fluid drained in the first week was similar in the lumbar drain and standard of care groups. The color difference in fluid from a ventricular and a lumbar drain when both are used simultaneously is visually striking (eFigure 1 in Patients in the lumbar drain group were noted to have significantly lower ICP (eFigures 4 and 5 in Vasospasm, regardless of its definition, was associated with the development of secondary infarctions. The lumbar drain and standard of care groups differed in the rate of secondary infarctions but showed similar vasospasm frequency and severity. This suggests additional mechanisms being necessary for the development of secondary infarctions beyond vasospasm of the large brain supplying vessels. Microcirculation disturbances are a factor difficult to assess at bedside. Techniques like local brain tissue oxygenation monitoring, detection of cortical spreading depolarizations, or continuous surface electroencephalography recording may provide further insight but were too infrequently used in the EARLYDRAIN trial for a sophisticated explanation.Assumed contraindications to a lumbar drainage are obstructive hydrocephalus and compressed basal cisterns. However, both lack a definition commonly agreed on. Data from traumatic brain injury show that cautious lumbar drainage may be used for treatment of refractory ICP.The rate of infections in the EARLYDRAIN trail reflects a mixed-grade aneurysmal subarachnoid hemorrhage population. More than half of affected patients develop fever, and roughly 20% develop pneumonia.Infarct detection at discharge was mainly performed using CT. Magnetic resonance imaging is likely to be a more sensitive measure but was not routinely used in the EARLYDRAIN trial. We did not use the current composite definition for delayed cerebral ischemia,The EARLYDRAIN trial was a randomized trial planned to closely reflect clinical routine. At the trial planning stage, the investigators had no agreement which specific group of patients would benefit from lumbar drainage with negligible risks. While cautious centers proposed to include only patients with good grades for safety reasons, others considered a lumbar drain as mandatory to ease surgery, especially in patients with poor grades with brain edema. Consequently, disease severity varied between centers, and patient inclusions reflect clinical equipoise of the local investigators. Therefore, despite that more than half of the patients were recruited in 2 centers only, we think the results of the EARLYDRAIN trial are generalizable for treatment after aneurysmal subarachnoid hemorrhage. | PMC10277935 |
Limitations | hypertension | CLOTS, CLOT, SUBARACHNOID HEMORRHAGE, MEDICAL COMPLICATION, HYPERTENSION | This trial has several limitations. First, we were unable to secure sufficient funding to allow timely completion of the EARLYDRAIN trial, prohibiting hiring of dedicated personnel.A significant number of patients in the lumbar drain group did not receive the allocated intervention for various reasons. Crossover patients did not reveal a particular pattern, and sensitivity analysis supported the findings from the intention-to-treat analysis. Patients, relatives, and acute care clinicians were not blinded to the intervention. Although this may be a source of bias, blinded outcome assessment of radiological imaging and clinical status at 6 months minimized this potential.We did not collect data on preexisting hypertension and other premorbid prognostic factors. We have no detailed information on the thickness of clots or the amount of intraparenchymal and intraventricular blood in the initial CT scan. We did not record medical complications during the clinical course, which happen frequently in patients with subarachnoid hemorrhage.The EARLYDRAIN trial did not investigate the additional application of clot thrombolysis or irrigation of the subarachnoid space. Also, we are unable to evaluate the benefit of possible higher drainage rates than the suggested 5 mL per hour, although some patients did have a higher drainage amount via lumbar route. This points to possible directions for future research. | PMC10277935 |
Conclusion | aneurysmal subarachnoid hemorrhage, lumbar cerebrospinal fluid, infarction | INFARCTION | In patients with aneurysmal subarachnoid hemorrhage, prophylactic lumbar cerebrospinal fluid drainage is warranted to lessen the burden of infarction at discharge and reduce the rate of unfavorable outcome at 6 months. Our findings support the use of a lumbar drain additional to standard of care. | PMC10277935 |
Abstract | PMC10511620 | |||
Background | TG, gastric cancer | GASTRIC CANCER | Distal gastrectomy (DG) for gastric cancer can cause less morbidity than total gastrectomy (TG), but may compromise radicality. No prospective studies administered neoadjuvant chemotherapy, and few assessed quality of life (QoL). | PMC10511620 |
Methods | tumors, TG | POSTOPERATIVE COMPLICATION, SECONDARY, TUMORS, GASTRIC ADENOCARCINOMA | The multicenter LOGICA-trial randomized laparoscopic versus open D2-gastrectomy for resectable gastric adenocarcinoma (cT1–4aN0–3bM0) in 10 Dutch hospitals. This secondary LOGICA-analysis compared surgical and oncological outcomes after DG versus TG. DG was performed for non-proximal tumors if R0-resection was deemed achievable, TG for other tumors. Postoperative complications, mortality, hospitalization, radicality, nodal yield, 1-year survival, and EORTC-QoL-questionnaires were analyzed using | PMC10511620 |
Results | Between 2015 and 2018, 211 patients underwent DG ( | PMC10511620 | ||
Conclusions | TG | COMPLICATIONS | If oncologically feasible, DG should be preferred over TG due to less complications, faster postoperative recovery, and better QoL while achieving equivalent oncological effectiveness. | PMC10511620 |
Mini-abstract | gastric cancer | COMPLICATIONS, GASTRIC CANCER | Distal D2-gastrectomy for gastric cancer resulted in less complications, shorter hospitalization, quicker recovery and better quality of life compared to total D2-gastrectomy, whereas radicality, nodal yield and survival were similar. | PMC10511620 |
Supplementary Information | The online version contains supplementary material available at 10.1007/s11605-023-05683-z. | PMC10511620 | ||
Keywords | PMC10511620 | |||
Introduction | Gastric cancer, TG, gastric cancer | GASTRIC CANCER, DISEASE, GASTRIC CANCER | Gastric cancer is the third leading cause of cancer-related mortality worldwide.Although both DG and TG are safe to perform, previous studies exposed several differences and concerns regarding their associated surgical and oncological outcomes.However, no prospective studies compared outcomes after neoadjuvant chemotherapy and few assessed lymph node retrieval or quality of life, of which none in Western populations. Furthermore, there is heterogeneity among studies, most studies were retrospective and did not address the surgeon’s experience, and not all studies reported follow-up. Moreover, mainly Eastern populations were investigated, who differ from Western patients in disease stage, age, comorbidities, and BMI. Therefore, the aim of the present study was to determine the role of DG and TG for Western gastric cancer patients, in particular after neoadjuvant chemotherapy, by comparing surgical and oncological outcomes including survival and quality of life after distal versus total D2-gastrectomy in the multicenter LOGICA-cohort. | PMC10511620 |
Methods | PMC10511620 | |||
Study Design | TG | SECONDARY, GASTRIC ADENOCARCINOMA | This study is a secondary analysis in the prospective, multicenter LOGICA-trial to compare surgical and oncological outcomes including QoL after DG versus TG for resectable gastric adenocarcinoma (cT1–4aN0–3bM0) in 10 Dutch hospitals. The randomized controlled LOGICA-trial (NCT02248519) compared laparoscopic versus open D2-gastrectomy and showed no significant differences in surgical nor oncological outcomes including QoL. The study protocol and results were published previously. | PMC10511620 |
Patient Selection and Randomization | The inclusion and exclusion criteria were listed in the LOGICA protocol. | PMC10511620 | ||
Staging and Treatment | tumor, tumors, TG | TUMOR, TUMORS, GASTRIC CANCER | Regional multidisciplinary tumor boards determined the staging and individual treatment strategy according to Dutch national guidelines, which is elaborated in the LOGICA-protocol.Consecutively, DG was performed for distal (pylorus, antrum) and middle (distal corpus) gastric cancer, whereas tumors located in the gastric cardia (Siewert type II/III according to TNM-8), fundus, upper corpus, or entire stomach were resected by TG. | PMC10511620 |
Surgeon Experience and Quality Control | ONCOLOGY | Prior to the trial start, all surgeons completed the European Society for Surgical Oncology (ESSO) Training Program on Minimally Invasive Gastrectomy and at least two laparoscopic gastrectomies per surgeon were centrally reviewed by study proctors (RvH and JR).The LOGICA-trial included a mandatory surgical quality control, which comprised central assessment of intraoperatively taken photographs from the performed D2-lymphadenectomy, for which feedback was prospectively provided to participating surgeons on weekly basis. | PMC10511620 | |
Outcome Measures | pneumonia, pancreatic injury, blood loss, abscess, TG, ileus | PNEUMONIA, BLOOD LOSS, WOUND INFECTION, POSTOPERATIVE COMPLICATION, ABSCESS, LEAKAGE, ATRIAL FIBRILLATION, COMPLICATIONS, ILEUS | The main outcome was overall postoperative complication rate after DG versus TG. In addition, both groups were compared regarding individual complications (i.e., anastomotic leakage, pneumonia, atrial fibrillation, ileus, abscess, pancreatic injury, chyle leakage, wound infection), mortality, oncological outcomes (e.g., radicality, marginal distances, lymph node yield, 1-year survival), intraoperative details (i.e., blood loss, operating time, conversion, additional organ resections), postoperative recovery (e.g., hospitalization, time to flatus and first oral intake, readmissions), and 1-year quality of life using EORTC QLQ-C30- and STO-22-questionnaires at baseline and after 6 weeks, 3, 6, 9, and 12 months. | PMC10511620 |
Statistical Analysis | Outcomes were compared using the (independent sample) unpaired | PMC10511620 | ||
Discussion | tumor, pneumonia, blood loss, tumors, TG, gastric cancer | TUMOR, PNEUMONIA, POSTOPERATIVE COMPLICATIONS, BLOOD LOSS, MINOR, LEAKAGE, ATRIAL FIBRILLATION, TUMORS, COMPLICATIONS, GASTRIC CANCER | This study aimed to determine the role of DG for Western gastric cancer patients by comparing surgical and oncological outcomes including quality of life after DG versus TG, in particular in a population where the vast majority of patients was treated with neoadjuvant chemotherapy. Patients selected to undergo DG experienced significantly fewer and less severe postoperative complications, also after correcting for baseline differences. Furthermore, DG-patients had better intraoperative surgical outcomes, shorter hospital and ICU stay, and quicker postoperative recovery compared to TG-patients. Moreover, the reported quality of life after DG was significantly better in most functional and symptom scales at one or all time points, and the significant differences were also clinically relevant based on previous guidelines.In the present study, both DG and TG were oncologically effective and oncological outcomes were concordant with current standards.Importantly, our results demonstrate that DG resulted in fewer and less severe postoperative complications (overall, anastomotic leakage, pneumonia, and atrial fibrillation), less blood loss and splenectomy, shorter operating time and hospital and ICU stay, quicker postoperative recovery, and better quality of life compared to TG. This is in line with a previous nationwide evaluation.Patients in the current study experienced significantly better quality of life after DG versus TG regarding most functional and symptom scales at one or all time points in the 1-year follow-up (predominantly ≥ 10 points difference), possibly as a consequence of functional preservation of part of the stomach. Importantly, all significant differences were also clinically relevant and categorized in medium (41%) or small differences (59%) based on previous guidelines, without any trivial (0%) differences.To complement the abovementioned, several recommendations for surgical decision making can be stated. The surgical strategy (DG or TG) should primarily be based upon achieving a radical D2-gastrectomy, and may secondarily be adjusted to ensure safety of surgery. It should be noted that there is not always a “choice” for surgeons between performing DG or TG; for instance, proximal tumors are not eligible for distal gastrectomy. In the current study, the differences in baseline characteristics reflect this surgical selection process. Notably, the R0-resection rates after DG and TG (98% versus 91%) should be interpreted within the context of these baseline differences, since the TG-group contained proximal tumors and had larger tumor diameters (The costs of surgery are not always incorporated when clinically considering distal or total gastrectomy; however, this is highly relevant for hospital management. In the LOGICA-trial, we had previously assessed the cost-effectiveness of D2-gastrectomy in detail: the mean total costs of D2-gastrectomy including costs associated with surgery (e.g., hospitalization, diagnostic modalities, complications, re-interventions, medication, emergency visits, rehabilitation and nursing homes, and productivity loss) noted €21,939 per distal and €31,583 per total D2-gastrectomy.Since patients selected for DG differ in baseline from TG-patients by definition as described, this limits statistical comparison to some extent. However, the baseline differences are inherent to the indication per surgical procedure (DG/TG), and our findings consistently support DG in alignment with previously mentioned studies. Furthermore, several details of the Roux-en-Y reconstruction, including length of Roux-limbs and antecolic/retrocolic position and jejunal pouch formation and size, were not standardized in the LOGICA-trial, which could have resulted in (minor) differences in QoL-results between DG and TG.In conclusion, Western gastric cancer patients selected for DG experienced fewer and less severe complications (overall, anastomotic leakage, pneumonia, atrial fibrillation), demonstrated quicker postoperative recovery, and reported substantial better quality of life, also after neoadjuvant chemotherapy, while oncological effectiveness after DG was safeguarded. Therefore, in selected patients where DG is oncologically feasible, DG should be preferred over TG. Alternatively, TG is safe and effective if adequate oncological control cannot be achieved with DG. To determine the optimal surgical strategy for each gastric cancer patient, it is crucial to individually balance radicality, surgical morbidity and quality of life.
| PMC10511620 |
Funding | The LOGICA-trial (NCT02248519) was funded by ZonMw (The Netherlands Organization for Health Research and Development), project number 837002502. | PMC10511620 | ||
Data Availability | Prof. dr. R. van Hillegersberf had full access to all trial data. The data are not publicly available for privacy reasons, and may be provided upon reasonable request. | PMC10511620 | ||
Declarations | PMC10511620 | |||
Disclosures | Richard van Hillegersberg: consulting or advisory role: intuitive surgical, Medtronic. Jelle Ruurda: consulting or advisory role: intuitive surgical. Lodewijk Brosens: advisory role: Bristol Myers Squibb. Grard Nieuwenhuijzen: consulting or advisory role: Medtronic. The other authors have no disclosures. All authors declared no conflicts of interest. | PMC10511620 | ||
References | PMC10511620 | |||
Background | prostate cancer, prostate | PROSTATE CANCER, PROSTATE | This study aimed to explore the value of combined serum lipids with clinical symptoms to diagnose prostate cancer (PCa), and to develop and validate a Nomogram and prediction model to better select patients at risk of PCa for prostate biopsy. | PMC10349516 |
Methods | TG, prostate | REGRESSION, PROSTATE | Retrospective analysis of 548 patients who underwent prostate biopsies as a result of high serum prostate-specific antigen (PSA) levels or irregular digital rectal examinations (DRE) was conducted. The enrolled patients were randomly assigned to the training groups (n = 384, 70%) and validation groups (n = 164, 30%). To identify independent variables for PCa, serum lipids (TC, TG, HDL, LDL, apoA-1, and apoB) were taken into account in the multivariable logistic regression analyses of the training group, and established predictive models. After that, we evaluated prediction models with clinical markers using decision curves and the area under the curve (AUC). Based on training group data, a Nomogram was developed to predict PCa. | PMC10349516 |
Results | TG, prostate cancer | REGRESSION, PROSTATE CANCER | 210 (54.70%) of the patients in the training group were diagnosed with PCa. Multivariate regression analysis showed that total PSA, f/tPSA, PSA density (PSAD), TG, LDL, DRE, and TRUS were independent risk predictors of PCa. A prediction model utilizing a Nomogram was constructed with a cut-off value of 0.502. The training and validation groups achieved area under the curve (AUC) values of 0.846 and 0.814 respectively. According to the decision curve analysis (DCA), the prediction model yielded optimal overall net benefits in both the training and validation groups, which is better than the optimal net benefit of PSA alone. After comparing our developed prediction model with two domestic models and PCPT-RC, we found that our prediction model exhibited significantly superior predictive performance. Furthermore, in comparison with clinical indicators, our Nomogram’s ability to predict prostate cancer showed good estimation, suggesting its potential as a reliable tool for prognostication. | PMC10349516 |
Conclusions | PROSTATE CANCER | The prediction model and Nomogram, which utilize both blood lipid levels and clinical signs, demonstrated improved accuracy in predicting the risk of prostate cancer, and consequently can guide the selection of appropriate diagnostic strategies for each patient in a more personalized manner. | PMC10349516 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12894-023-01291-w. | PMC10349516 | ||
Keywords | PMC10349516 | |||
Introduction | cancer, prostate, Prostate cancer, high-density lipoprotein, TG, prostate cancer | CANCER, PROSTATE CANCER, PROSTATE CANCER, PROSTATE | Prostate cancer (PCa) remains the most common cause of cancer-related mortality among men worldwide, and they were rapidly increasing in Asia as well [In clinical practice, prostate biopsy has long been recognized as the most reliable method for identifying and diagnosing prostate cancer, earning its status as the gold standard. The decision to perform a prostate biopsy is influenced by various factors, including the level of serum prostate-specific antigen (PSA) and its related factors, as well as the findings of a digital rectal examination (DRE) and imaging. However, the commonly employed methods for PCa screening, such as the PSA test, were subjective but not specific enough. It led to the increased risk of unnecessary invasive prostate biopsy. Then, alternate PCa diagnosis strategies were required to prevent men who are unlikely to have prostate cancer from undergoing potentially morbid or invasive procedures.To address these issues, clinical prediction models had been developed in some Western countries to help inform medical decisions by assessing the risk of cancer in a population individually, thereby reducing unnecessary punctures and increasing positive puncture rates, which were more accurate and scientific than traditional methods based on PSA and DRE. So far, more than a dozen models have been developed in Western countries to predict prostate cancer risk, with the PCPT-RC [Cholesterol was an essential component in the plasma membrane [Thus, an analysis of serum lipid profiles, such as TC (cholesterol), TG (triglyceride), HDL (high-density lipoprotein), LDL (low-density lipoprotein), apolipoprotein AI (apo AI), apolipoprotein B (apo B), and blood PSA levels was conducted retrospectively to determine if serum lipid profile may help optimize prostate cancer diagnosis. | PMC10349516 |
Materials and methods | PMC10349516 | |||
Recruiting patients | prostate, diabetes | PROSTATE, ACUTE BACTERIAL PROSTATITIS, BENIGN PROSTATIC HYPERPLASIA (BPH), HIGH BLOOD PRESSURE, PROSTATE CANCER, DIABETES | From January 2016 to December 2022, 800 patients who underwent transrectal prostate puncture guided by transrectal ultrasonography (TRUS) (12 + X core, all patients underwent preoperative magnetic resonance imaging (MRI) of the prostate, followed by 12-core systematic biopsy with or without targeted biopsy based on the MRI results) in the department of urinary surgery of Foshan Hospital of Traditional Chinese Medicine were recruited. All prostate biopsies were conducted by urologists with more than ten years of working experience in our department. The indications for prostate biopsy were the following: (1) tPSA > 10.0 ng/ml. (2) tPSA > 4.0ng/ml and < 10.0ng/ml with suspicious fPSA/tPSA < 0.16. (3) Affirmative outcomes identified through a DRE for any level of tPSA, and (4) positive findings from imaging techniques like TRUS and MRI have been observed regardless of the level of tPSA. The exclusion criteria were as detailed below: (1) 20 patients previously treated with prostate surgery or previously diagnosed with prostate cancer. (2) 43 patients who received 5 alpha-reductase inhibitors or who had urethral catheters in place, or who had previously undergone invasive therapy for benign prostatic hyperplasia (BPH). (3) 32 patients with acute bacterial prostatitis or other inflammatory systemic illnesses. (4) 54 patients without complete clinical data. (5) 103 patients with high blood pressure, diabetes, or taking lipid-lowering drugs, these patients may have taken lipid-lowering medication in the past or currently. 548 cases were included eventually. The study received official approval from the ethics committee of Foshan Hospital of Traditional Chinese Medicine (20220520). Before transrectal ultrasound-guided prostate puncture, all patients provided informed consent. | PMC10349516 |
Clinical information | TG, prostate | PROSTATE | The baseline information was retrospectively acquired from the clinical digital information including age, BMI (body mass index), serum PSA (total PSA and free PSA), f/tPSA (free/total PSA ratio), prostate volume (PV), prostate-specific antigen density (PSAD), TC, TG, HDL, LDL, apo A-1, apo B, DRE results, TRUS finding. f/tPSA was calculated using free PSA and total PSA. PV was based on TRUS, calculated as 0.52 × length × width × height. PSAD was computed by combining total PSA and PV. | PMC10349516 |
Nomogram development and evaluating | REGRESSION | To construct an accurate nomogram that predicts the likelihood of PCa, we carried out multivariable logistic regression analyses to determine the correlation between the relevant factors and PCa. We utilized the forward method in multivariable logistic regression analysis to identify independent predictors, and subsequently, to determine the significant variables for creating nomograms. To assess the risk model’s utility, receiver operator characteristic (ROC) curves were generated and the corresponding area under the curves (AUC) values was compared. To determine the statistical significance between the AUC values, the DeLong method was employed. The Nomogram was developed by randomly selecting 384 (70%) cases, with 164 (30%) cases set aside for validation by the R package “verification”. A nomogram that predicts the risk of PCa was developed based on independent risk factors. The calibration curve was employed to evaluate the consistency of nomogram-predicted probabilities with observed probabilities. To evaluate the net benefit obtained from utilizing the developed nomogram, a decision curve analysis (DCA) was performed. Data were plotted using R software v.4.1.0 (R Foundation, Vienna, Austria) for the nomogram (R package ‘rms’), calibration plot (R package ‘rms’), and DCA (R package ‘rmda’). | PMC10349516 | |
Statistical analysis | REGRESSION | The distribution of categorical variables was evaluated using Pearson’s Chi-square test, while the distribution of continuous variables was assessed using either the Mann-Whitney U test or Student’s t-test, depending on the distribution of the data. The multivariable logistic regression analysis was conducted using the SPSS 24.0 software. (SPSS Inc., Chicago, IL). The AUC, sensitivity, specificity, and positive and negative predictive values (PPV/NPV) for each method were calculated using MedCalc 19.3. The optimal cutoff values for the biopsy threshold, which balanced sensitivity and specificity, were determined using Youden’s J index (sensitivity + specificity − 1). Statistical significance was considered for all tests with a two-sided p-value less than 0.05. | PMC10349516 | |
Results | PMC10349516 | |||
Multivariable analysis predicting PCa | TG, prostate cancer | REGRESSION, PROSTATE CANCER | In multivariable logistic regression analysis, tPSA (P < 0.001), f/tPSA (P = 0.018), PSAD (P = 0.030), TG (P = 0.006), LDL (P < 0.001), DRE (P = 0.002) and TRUS (P = 0.009) were significantly related to the presence of PCa in biopsy (Table
Multivariate logistic regression models in the training group
Diagnostic accuracy of our model and other models using validation group
Receiver operating characteristic curve (ROC) of Model 1 and Model 2 for predicting prostate cancer risk. The | PMC10349516 |
Nomogram to estimate the risk of PCa | TG | REGRESSION, PROSTATE | Using multivariate logistic regression, a predictive model was constructed. 7 of the initial 13 variables were incorporated into the predictive model (model 2), namely tPSA, f/tPSA, PSAD, TG, LDL, DRE, and TRUS, as predictors. Each variable is scored, and a straight line is drawn from the total score to determine harboring PCa probability (Fig.
Diagnostic values of models in the training group and validation group for the results of prostate biopsy
Comparison of diagnostic values of other prediction models with that of our models
Nomogram predicts the probability of PCa. | PMC10349516 |
Predictive model validation | prostate cancer | PROSTATE CANCER | The calibration plot, which used internal bootstrap sampling (n = 1000), indicated a high degree of consistency between the bias-corrected curve and the ideal curve (the 45-degree line) both in the training and validation sets, indicating that our nomogram accurately predicted the occurrence risk and demonstrated good calibration (Fig.
Calibration curves of the predictive prostate cancer risk nomogram. The
Decision curve analysis for the prostate cancer risk nomogram. The | PMC10349516 |
Discussion | obesity, high-grade prostate cancer, RP, prostate malignancies, cancer, prostate, PCa, high-grade, prostate tumor, hypertriglyceridemia, metabolic syndrome, TG, prostate cancer, dyslipidemia | OBESITY, HYPERLIPIDEMIA, PROLIFERATION, CANCER, DISEASE, PROSTATE CANCER RECURRENT, COMPLICATIONS, PROSTATE, PROSTATE TUMOR, HYPERTRIGLYCERIDEMIA, METABOLIC SYNDROME, PROSTATE CANCER, TUMORIGENESIS, DYSLIPIDEMIA | PCa is a complicated disease characterized by phenotypes, and each patient appears to have an “individual” process. The lifestyle and nutritional preferences of an individual could influence the development of PCa. There was strong evidence that obesity, hyperlipidemia, and other components of metabolic syndrome significantly elevate the risk of developing prostate cancer [Although the relationship between dyslipidemia and PCa has been extensively explored, the underlying mechanism remains unclear. Many hypotheses have been offered to explain the association between lipids and the growth and development of PCa. Activation of the sterol regulatory element-binding protein pathway by androgens promoted the expression of lipogenic genes, which stimulated the accumulation of neutral lipids (triglycerides and cholesteryl esters) and tumorigenesis, thereby stimulating prostate tumor growth [Multiple studies indicated that elevated LDL levels were associated with an increased risk of cancer. LDL promoted the proliferation, migration, and invasion of prostate cancer cells by inducing JAK1/JAK2/STAT3 activation and upregulated the expression of several oncogenic gene products [In contrast to our findings, some studies discovered that lower LDL levels in RP patients were an independent predictor of prostate cancer recurrence [According to our investigation into the relationship between TG and prostate malignancies, we found that elevated levels of serum TG were associated with a higher risk of developing prostate cancer. The metabolism of TG produces vital fatty acids [Additionally, hypertriglyceridemia was characterized by the presence of small dense LDL particles and cholesterol-rich remnant lipoproteins (RLP), which were the products of the hydrolysis of chylomicrons and VLDL [Lipids were routinely checked by clinical patients, and this was a simple procedure that patients readily accept. We found that the ROC curve study revealed that the prediction model 2 was significantly superior to model 1, PCPT-CRC, and two domestic prediction models, suggesting that lipids plus the common clinical indicators (tPSA, f/tPSA, PSAD, DRE, TRUS) were much more predictive of prostate cancer patients than the common clinical indicators alone, which not only improved the biopsy rate of patients with prostate cancer but also reduced the need for unnecessary invasive testing. In consideration of the potential risks associated with false-negative prostate cancer and complications of prostate biopsy, we determined a cut-off value for AUC when the Jorden Index reached its optimal level. The cut-off value of AUC in the training group was determined to be 0.502. The sensitivity, specificity, positive predictive value, negative predictive value, false negative rate, and false positive rate were determined to be 74.03%, 82.76%, 78.3%, 25.97%, and 17.24%, respectively. Through the incorporation of a threshold value of 0.502 in the training group, our prediction model successfully prevented 95.25% of unnecessary prostate biopsies with 38.96% of missed positive cases. Based on our findings, it is recommended to perform a prostate biopsy when the prediction probability exceeds 0.502, while active monitoring may be considered for cases below this threshold.Despite these promising results, our study is not without limitations: (1) this study was retrospective, hence, selection bias was inevitable; (2) The sample size of the single-center study was modest, and a subsequent multicenter cooperative study was required to confirm the conclusion; (3) The prediction model lacked external validation and follow-up external multicenter data were required; (4) A risk calculator developed and validated in this study was only used to predict prostate cancer on initial prostate biopsy, but failed to distinguish between high-grade and low-grade prostate cancer. In our further studies, we would work in predicting the model of high-grade prostate cancer (defined as a Gleason score sum of 7 or higher).In summary, the main objective of our study was to evaluate the diagnostic efficacy of combining blood lipid levels and clinical symptoms in the diagnosis of prostate cancer. We established an individualized nomograph prediction model to help identify patients with prostate cancer at an early stage and provide individualized risk calculation to reduce unnecessary puncture biopsies. | PMC10349516 |
Electronic supplementary material | REGRESSION | Below is the link to the electronic supplementary material.
Additional File Table 1: Multivariate stepwise logistic regression analysis for predicting PCa in the training group for Model 1.
Additional File Table 2: Multivariate stepwise logistic regression analysis for predicting PCa in the training group for Model 2. | PMC10349516 | |
Acknowledgements | None. | PMC10349516 | ||
Authors’ contributions | W.W. | F.F., Y.Z. and Z.X. conceptualized and designed the framework of this study. Y.C. and F.L. completed the collation and conducted all analyses. Y.C., J.H. and Y.M. provided clinical expertise and aided in interpreting the results. P.Z., W.W. and H.Z. drafted the manuscript, figure, and table. All authors reviewed and edited the final manuscript. | PMC10349516 | |
Funding | This project was supported by Foshan “14th Five-Year” Medical Cultivation Key Specialties Construction Project (FSPY145003) and Clinical Drug Research. Foundation of Guangdong Province (Special Fund for Orthopedics Analgesia in Surgical Pharmacy) (2021ZT13). The funding bodies played no role in the design of the study and collection, analysis, interpretation of data, and in writing the manuscript. | PMC10349516 | ||
Data availability | The data are not publicly shared because we do not have permission from the Ethics Review Committee to distribute the data. The analytic methods are available from the corresponding authors upon reasonable request. | PMC10349516 | ||
Declarations | PMC10349516 | |||
Ethics approval and consent to participate | The studies involving human participants were reviewed and approved by the Ethics Review Committee of Foshan Hospital of Traditional Chinese Medicine (Approval number. 20220520). All procedures followed applicable guidelines and regulations. Informed written consent was also obtained from the patients in this study. | PMC10349516 | ||
Consent for publication | Not applicable. | PMC10349516 | ||
Competing interests | The authors state that they have no competing interests in this study. | PMC10349516 | ||
References | PMC10349516 | |||
Background | To investigate if the correlation between left and right cerebral tissue oxygen saturation (SctO | PMC9906862 | ||
Methods | lung cancer | LUNG CANCER | Patients who underwent surgery for lung cancer were enrolled. Left and right SctO | PMC9906862 |
Results | Left–right SctO | PMC9906862 | ||
Conclusions | The correlation between left and right SctO | PMC9906862 | ||
Trial registration | SECONDARY | This study was a secondary analysis of a cohort study approved by the Clinical Research Review Board of Peking University First Hospital (#2017–1378) and was registered in the Chinese Clinical Trial Registry on 10/09/2017 ( | PMC9906862 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12871-023-02001-7. | PMC9906862 | ||
Keywords | PMC9906862 | |||
Background | hypoxia, hypercapnia | HYPOXIA | Near-infrared spectroscopy (NIRS) has been widely used in patients undergoing non-cardiac surgery because it is a non-invasive, continuous, and timely method for monitoring regional cerebral tissue oxygen saturation (SctOEvidence in healthy volunteers showed that respiratory parameters significantly influence the accuracy of SctOOne-lung ventilation (OLV) is a necessary technique in thoracic surgery. The incidences of hypoxia and hypercapnia are as high as 50% during OLV [The present study was primarily designed to investigate whether OLV influences the agreement between the left and right SctO | PMC9906862 |
Methods | PMC9906862 | |||
Ethic and registration | SECONDARY | This study was a secondary analysis of a cohort study which was approved by the Clinical Research Review Board of Peking University First Hospital (#2017–1378) and registered in the Chinese Clinical Trial Registry ( | PMC9906862 | |
Patient inclusion and exclusion criteria | Adult patients (age ≥ 55-year-old) who received OLV under general anesthesia with or without epidural or paravertebral block were enrolled. Patients were excluded if they met any of the following criteria: 1) no record of SctO | PMC9906862 | ||
Primary outcome | BLIND | The primary outcome was agreement of left–right SctOBaseline measurements were obtained before anesthesia induction, with the patients resting and breathing room air. The screen of the tissue oximeter was covered with an opaque bag to blind the anesthesia providers for monitoring. Dedicated research personnel checked the tissue oximeter every 10 min to ensure proper function. | PMC9906862 | |
Secondary outcomes | Confusion | Secondary outcomes included the correlation of left–right SctOCorrelations of left–right ScODelirium was assessed twice daily (at 06:00–08:00 and 18:00–20:00) within postoperative 5 days using the Chinese version of the Confusion Assessment Method (CAM) in non-intubated patients and the CAM for intensive care unit (CAM-ICU) in intubated patients [ | PMC9906862 | |
Anesthesia and perioperative care | pain | All patients underwent the same monitoring on arrival at the operating room, including SpOAnesthesia was induced using propofol (2–4 mg/kg) and sufentanil (site-effect concentration, 0.2A double-lumen endotracheal tube was used for intubation. The tidal volume was set at 6Postoperative pain was assessed using numeric rating scale (an 11-point scale where 0 indicates no pain and 10 indicates the worst pain). Patient-controlled intravenous analgesia (PCIA) was used to maintain a pain score of 3 or lower. The program of PCIA was set to deliver a background infusion of sufentanil at 1.25 μg/h and a 2.5 μg bolus with a lock-out interval of 8 min for breakthrough pain [ | PMC9906862 | |
Statistical analysis | PMC9906862 | |||
Power calculation | The Pearson’s correlation coefficient of left–right SctO | PMC9906862 |
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