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Author contributions | MP, FM | EP, MP, JE, and FM: conceptualization and methodology, writing—review and editing, and project administration.. TM: statistics. EP and MP: coordinating clinical investigators. EP, MP, JE, FM, AK, MG, JO-S, IK, JL-A, and ES: writing and original draft preparation. All authors contributed to the writing—review and editin... | PMC10393266 | |
Conflict of interest | FM | JE, FM, and ESc are employees of Dr. Kurt Wolff GmbH and Co. KG, Bielefeld, Germany. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10393266 | |
Publisher's note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10393266 | ||
Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file. | PMC10393266 | ||
References | PMC10393266 | |||
1. Introduction | muscle mass, muscle soreness, muscle damage, tissue damage | INFLAMMATORY RESPONSE | The post-exercise inflammatory response, characterized by muscle damage and elevated plasma levels of creatine kinase (CK), is a normal physiological process that is thought to play a vital role in tissue damage repair and enhancing muscle adaptation [Daily dietary protein intake is an important factor for muscle repai... | PMC9867418 |
2. Materials and Methods | PMC9867418 | |||
2.1. Participants | Participants were recruited in July 2021 via the Nijmegen Exercise Study database [ | PMC9867418 | ||
2.2. Study Design | In this randomized double-blind placebo-controlled trial, a total of 47 participants were randomly allocated to a whey protein, pea protein or placebo supplement group. Participants were invited for 5 study visits at the department of Physiology of the Radboud university medical center ( | PMC9867418 | ||
2.3. Supplementation Protocol | Participants were instructed to consume the assigned supplement twice a day for a period of 13 days (10 days prior to the exercise bout and 3 days post exercise). This pre-loading period was chosen as previous studies have demonstrated its importance [ | PMC9867418 | ||
2.4. Measurements | PMC9867418 | |||
2.4.1. Blood Samples | muscle damage, tissue damage | Venous blood was drawn from the antecubital vein during each visit, and serum and lithium heparin plasma samples were stored at −80 °C until further analyses. Analyses were performed by trained technicians using standard operating procedures. CK and LDH levels were measured using a C8000 module C720 clinical chemistry ... | PMC9867418 | |
2.4.2. Habitual Walking Characteristics | The habitual walking activity in the past year (July 2020–July 2021) was assessed at baseline using an online questionnaire. Participants were asked to indicate how frequent they walked per week, the average number of kilometers per walking bout and how many weeks in the past year they performed the reported walking bo... | PMC9867418 | ||
2.4.3. Exercise Intervention | Participants were instructed to perform a single walking bout with a minimum of 20 km and a maximum of 30 km. Walking distance, exercise duration and whether participants suffered from physical discomfort were registered directly following the exercise bout. | PMC9867418 | ||
2.4.4. Muscle Soreness | Muscle soreness, pain | Muscle soreness was assessed using a Numeric (pain) Rating Scale (NPRS) where participants could mark a pain score between no pain at all (NRS = 0) and extremely painful (NRS = 10). NPRS scores of 1–5 were considered as mild pain, 6–7 as moderate pain and >8 as severe pain [ | PMC9867418 | |
2.4.5. Dietary Intake | Food consumption patterns were assessed using an online Dutch tool (i.e., ‘Mijn Voedingscentrum’) [ | PMC9867418 | ||
2.4.6. Muscle Strength | Handgrip strength of the right hand was measured with a hydraulic, analogue handheld dynamometer (JAMARLeg muscle strength was measured in kilograms with an EN-Dynamic seated leg press (Enraf-Nonius, Rotterdam, The Netherlands). After adjusting the seat and a warm-up, participants had to perform one leg press per fixed... | PMC9867418 | ||
2.4.7. Anthropometrics and Muscle Mass | skeletal muscle mass | Body height and weight of the participants were measured. Total skeletal muscle mass (SMM) of both legs were estimated with bioelectrical impedance analyses (InBody 770 Body Composition Analyzed, Seoul, Republic of Korea) [ | PMC9867418 | |
3. Statistical Analysis | muscle soreness | Statistical analyses were performed using SPSS software (IBM SPSS Statistics for Windows, Version 25.0 IBM Corp., Armonk, NY, USA) and graphs were made using Graphpad Prism 9. All continuous variables and the residuals of the variables used in the linear-effects model were visually inspected and tested for normality wi... | PMC9867418 | |
4. Results | PMC9867418 | |||
4.1. Participants | muscle cramps | One participant from the placebo group withdrew from further participation after the baseline measurement due to personal reasons not related to the study protocol. Another participant from the pea supplement group dropped out due to heavy muscle cramps during the walking exercise bout and was therefore unable to compl... | PMC9867418 | |
4.2. Habitual Dietary Intake and Walking Activity | Total energy intake was 2078 ± 528 kcal and comparable across groups ( | PMC9867418 | ||
4.3. Exercise Bout Characteristic | Participants covered a walking distance of 24.3 ± 4.9 km with a duration of 5.2 ± 1.1 h. Walking distance and exercise duration did not differ across the three groups ( | PMC9867418 | ||
4.4. Muscle Damage | The time-dependent exercise-induced increase in creatine kinase (CK) levels were significantly different between the three groups (Pinteraction = 0.018). Peak CK concentrations (+24 h) were significantly lower in the whey (175 ± 90 U/ | PMC9867418 | ||
4.5. Muscle Parameters | Maximum recorded handgrip strength was not different between groups ( | PMC9867418 | ||
5. Discussion | muscle soreness, muscle damage, skeletal muscle mass | SECONDARY | The aim of this randomized double-blind placebo-controlled trial was to assess the effect of pea protein and whey protein supplementation versus placebo on exercise-induced increases in muscle damage markers within older adults. We found that long-distance walking exercise provoked muscle damage, with peak CK levels ar... | PMC9867418 |
6. Conclusions | muscle soreness, muscle damage, skeletal muscle mass | EXERCISE INDUCED MUSCLE DAMAGE | Our randomized double-blind placebo-controlled trial demonstrated that 13 days with 25 g per day of pea protein suppletion did not attenuate exercise-induced muscle damage in older adults compared to placebo. In contrast, the whey protein group showed lower serum CK levels at 24 h post exercise compared to pea protein ... | PMC9867418 |
Author Contributions | Conceptualization and methodology, M.S., Y.A.W.H., C.C.W.G.B., M.C.A.S. and M.T.E.H.; investigation: M.S., Y.A.W.H., C.C.W.G.B., T.M.H.E. and M.T.E.H.; formal analysis: M.S., M.C.A.S. and T.M.H.E.; writing—original draft preparation: M.S. and L.K.; writing—review and editing: M.S., L.K., Y.A.W.H., C.C.W.G.B., M.C.A.S.,... | PMC9867418 | ||
Institutional Review Board Statement | The study conformed to the principles of the Declaration of Helsinki, was approved by the local Medical Ethical committee (Study-ID: NL77522.091.21) and registered at the Dutch trial registry (#NL9499). | PMC9867418 | ||
Informed Consent Statement | All participants gave signed consent to participate in the research study. | PMC9867418 | ||
Data Availability Statement | The datasets generated and/or analyzed during the current study are not publicly available due to the fact that study participants can be identified based on age, sex and finish time, but the pseudonymized dataset is available from the corresponding author upon reasonable request. | PMC9867418 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC9867418 | ||
Abbreviations | PMC9867418 | |||
References | muscle mass | Overview of study timeline and measurements. #1–5 means visit 1–5.Change in Creatine kinase (CK) (Muscle parameters. Changes in handgrip strength (Nutritional composition of whey, pea and placebo supplements.** Branches Chain Amino Acids (BCAA’s).Baseline characteristics of the total group and specified for the whey-, ... | PMC9867418 | |
INTRODUCTION | B-cell lymphomas, DLBCL of germinal center B-cell, hypophosphatemia, neutropenia, toxicity, treatment-emergent adverse, B-cell lymphoma, lymphoid malignancy, DLBCL, lymphoma, non-Hodgkin’s lymphoma | HYPOPHOSPHATEMIA, NEUTROPENIA, DISEASE, B-CELL LYMPHOMA, SOLID TUMORS, LYMPHOMA, DIFFUSE LARGE B-CELL LYMPHOMA | We report an updated analysis from a phase I study of the spleen tyrosine kinase (SYK) and FMS-like tyrosine kinase 3 inhibitor mivavotinib, presenting data for the overall cohort of lymphoma patients, and the subgroup of patients with diffuse large B-cell lymphoma (DLBCL; including an expanded cohort not included in t... | PMC9882996 |
RESULTS | PMC9882996 | |||
Patients | DLBCL | A total of 124 patients were enrolled; 17 patients were enrolled in the dose escalation phase and received mivavotinib at the following doses: 60 mg QD (Of the patients with DLBCL, 12 were enrolled during dose escalation, 41 were enrolled to the first expansion cohort, and 36 were enrolled to the second expansion cohor... | PMC9882996 | |
Patient disposition flow diagram. | lymphoma, DLBCL | LYMPHOMA, DISEASE CHARACTERISTIC | Patient baseline demographics and disease characteristics for all lymphoma patients and all DLBCL patients are shown in | PMC9882996 |
Efficacy | BEST | Best overall responses to mivavotinib are shown in | PMC9882996 | |
Best overall response | DISEASE | Percentages are based on the total number of patients in the response-evaluable population in each column. 2-sided 95% exact binomial CIs were used. Abbreviation: SD: stable disease. | PMC9882996 | |
Kaplan–Meier curve for estimated median DOR in the DLBCL combined cohort (response-evaluable population). | lymphoma, PD, death, DLBCL | LYMPHOMA, EVENTS, EVENT, DISEASE PROGRESSION | DOR was defined as the time from the date of first documentation of PR or better to the date of first documentation of PD or relapse. Among patients with CR, no patients had a PD/relapse event, and data were censored with a range of less than one month (1 day) to 63.0 months with responses ongoing for all 14 patients a... | PMC9882996 |
Kaplan–Meier curve for estimated median PFS in the DLBCL combined cohort (safety population). | lymphoma, death, DLBCL | LYMPHOMA, DISEASE | PFS is defined as the time from the date of the first study treatment administration to the date of the first documentation of progressive disease or death.The median overall survival (OS) was 8.3 months (95% CI, 3.7–NE) in patients with lymphoma and 3.9 months (95% CI, 2.1–NE) in patients with DLBCL. Overall, 52 patie... | PMC9882996 |
Safety | lymphoma, DLBCL | LYMPHOMA | All patients received at least one dose of mivavotinib and were evaluable for safety. Patients received a median of 2 treatment cycles (range 1–68), and the median treatment duration was 6.8 weeks for all patients with lymphoma and 6.0 weeks for patients with DLBCL. Safety is summarized in | PMC9882996 |
Overview of TEAEs (safety population) | Deaths | ADVERSE EVENT | TEAEs are defined as any adverse event that occurs after administration of the first dose of study treatment through 28 days after last dose of study treatment, or until the start of subsequent antineoplastic therapy. Deaths occurred within 28 days of last treatment dose. Percentages are based on the number of patients... | PMC9882996 |
Most frequent TEAEs occurring in ≥10% of patients by preferred term (safety population) | ADVERSE EVENT | TEAEs are defined as any adverse event that occurs after administration of the first dose of study treatment through 28 days after the last dose of study treatment, or until the start of subsequent antineoplastic therapy. Abbreviations: ALT: alanine aminotransferase; CPK: creatine phosphokinase. | PMC9882996 | |
Most common grade ≥3 TEAEs occurring in ≥10% of patients by preferred term (safety population) | lymphoma, TEAE | LYMPHOMA, ADVERSE EVENT | TEAEs are defined as any adverse event that occurs after administration of the first dose of study treatment through 28 days after the last dose of study treatment, or until the start of subsequent antineoplastic therapy.All patients with lymphoma experienced at least one TEAE; 96% experienced a grade ≥3 TEAE, and 76% ... | PMC9882996 |
DISCUSSION | deaths, pneumonitis, hypophosphatemia, pneumonia, neutropenia, metabolic disorder, toxicity, respiratory failure, thrombocytopenia, anemia, DLBCL, GCB and non-GCB DLBCL, lymphoma, lymphoma malignancies | PNEUMOCYSTIS PNEUMONIA, PNEUMONITIS, HYPOPHOSPHATEMIA, PNEUMONIA, NEUTROPENIA, METABOLIC DISORDER, RESPIRATORY FAILURE, DISEASE, THROMBOCYTOPENIA, SOLID TUMORS, OPPORTUNISTIC INFECTION, ANEMIA, MULTIORGAN FAILURE, LYMPHOMA, COMPLICATIONS | Primary data from this phase I, first-in-human study investigating the safety, tolerability, and preliminary efficacy of SYK/FLT3 inhibitor mivavotinib, conducted in patients with advanced solid tumors or lymphoma malignancies, were previously reported [The ORR and CR rates reported here for all patients with lymphoma ... | PMC9882996 |
MATERIALS AND METHODS | PMC9882996 | |||
Study design | lymphoma, toxicity, lymphoid malignancies, DLBCL | LYMPHOMA, DISEASE PROGRESSION, CLL, SOLID TUMORS | This was an open-label, multicenter, phase I, dose escalation and expansion study of QD, oral, single-agent mivavotinib in patients with advanced solid tumors or lymphoid malignancies. The full study design and methods have previously been reported [Briefly, in the dose escalation phase, adults with a confirmed diagnos... | PMC9882996 |
Patients | malignant lymphoma, DLBCL, Lymphoma | LYMPHOMA, DISEASE, MALIGNANT LYMPHOMA, LYMPHOMA | Lymphoma patients enrolled in both the escalation and expansion phases had histologically or cytologically confirmed lymphoma, according to the modified International Working Group (IWG) 2007 criteria for malignant lymphoma [Patients enrolled in the first DLBCL expansion cohort had pathologically confirmed DLBCL with a... | PMC9882996 |
Assessments | death, toxicity, TTP, DLBCL, PD, lymphoma, Cancer | DISEASE PROGRESSION, ADVERSE EVENT, ADVERSE EVENT, DISEASE, LYMPHOMA, TTP, CANCER | Efficacy endpoints including ORR, DOR, PFS, TTP and OS were analyzed for all patients with lymphoma, including the additional DLBCL expansion cohort, and for the full DLBCL subgroup (both expansion cohorts and the escalation cohort combined), based on data collected up to June 29, 2021. This report includes extended fo... | PMC9882996 |
Data sharing statement | Requests for de-identified datasets for the results reported in this publication will be made available to qualified researchers following submission of a methodologically sound proposal. Data will be made available for such requests following online publication of this article and for 1 year thereafter in compliance w... | PMC9882996 | ||
SUPPLEMENTARY MATERIALS | PMC9882996 | |||
ACKNOWLEDGMENTS | RP, TG | ONCOLOGY, EMD | This study was sponsored by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. We thank all of the patients and their families, and the investigators and staff at all clinical sites, for their participation in the trial. The authors acknowledge Tori Gordon, BSc, of Ash... | PMC9882996 |
Abbreviations | alanine aminotransferaseautologous stem-cell transplantaspartate aminotransferaseB-cell receptorCD19-targeted chimeric antigen receptorconfidence intervalchronic lymphocytic leukemiacreatine phosphokinasecomplete responsediffuse large B-cell lymphomaduration of responseEpstein Barr Virus-positive post-transplant lympho... | PMC9882996 | ||
REFERENCES | PMC9882996 | |||
Objectives | stroke, acute ischemic stroke, AIS | STROKE, RECURRENCE | We investigated the efficacy of intensive rosuvastatin therapy plus 7-day dual antiplatelet therapy (DAPT) in reducing stroke recurrence for patients with acute ischemic stroke (AIS) and compared subgroups of patients. | PMC9941271 |
Methods | bleeding, stroke, liver injury, statin-associated myopathy, SAPT | STROKE, BLEEDING, RECURRENCE, ISCHEMIC STROKE | We enrolled patients with AIS whose time of onset to medication was ≤ 72 h, and the baseline scores of NIHSS (bNIHSS) were 0–10. The patients received intensive rosuvastatin therapy plus 7-day DAPT with aspirin and clopidogrel (study group) or rosuvastatin plus single antiplatelet therapy (SAPT, control group). The pri... | PMC9941271 |
Results | RECURRENT STROKE | Recurrent stroke occurred in 10 patients in the study group and 42 patients in the control group (hazard ratio [HR], 0.373, 95% confidence interval [CI], 0.178–0.780; | PMC9941271 | |
Conclusions | stroke, bleeding, statin-associated | ADVERSE EVENTS, STROKE, BLEEDING | Without increasing bleeding and statin-associated adverse events, intensive rosuvastatin therapy plus 7-day DAPT significantly reduced the risk of recurrent stroke, especially for subgroups with high-risk factors. | PMC9941271 |
Supplementary Information | The online version contains supplementary material available at 10.1007/s00228-022-03442-8. | PMC9941271 | ||
Keywords | PMC9941271 | |||
Introduction | DISORDER OF LIPID METABOLISM, DYSFUNCTION, ARTERIAL THROMBOSIS | Disorder of lipid metabolism, dysfunction of endothelial cells, and aggregation of many inflammatory factors are the external conditions of arterial thrombosis [Intensive statin therapy is commonly combined with dual antiplatelet therapy (DAPT) in patients with ACS after percutaneous coronary intervention, stent implan... | PMC9941271 | |
Materials and methods | PMC9941271 | |||
Patients | infarction lesions, Stroke | EMERGENCY, STROKE | We recruited patients aged 18 years or older who were admitted to the Emergency Department of our hospital from October 2016 to December 2019. Computed tomography (CT) and magnetic resonance imaging (MRI) of the head was used to confirm the new focal infarction lesions within 72 h after the onset. Their National Instit... | PMC9941271 |
Therapy regimens | reduced recurrent vascular events | Patients in the study group received DAPT + intensive rosuvastatin therapy: aspirin (Bayer, 100 mg per tablet) 100 mg/d with an initial dose of 300 mg for 90 days, clopidogrel (Sanofi, 75 mg per tablet) 75 mg/d with an initial dose of 75–300 mg determined based on the clinical symptoms for 7 days, plus rosuvastatin (Na... | PMC9941271 | |
Assessment criteria | fecal occult blood, Bleeding, GUSTO, coronary occlusion, neurological deficits, neurological deficit symptoms | BLEEDING, EVENTS, CORONARY OCCLUSION, ISCHEMIC STROKE | We assessed focal neurological deficits by assessing the bNIHSS, which ranges from 0 to 43, with higher scores indicating worse deficits [Recurrent ischemic stroke—the aggravation of existing clinical symptoms or the emergence of new focal neurological deficit symptoms within 90 days after the first treatment—was confi... | PMC9941271 |
Statistical analysis | This study adopted an incomplete randomized controlled trial design, with Type I Error α = 0.05 and power of test (1 − β) = 0.85. The PASS 15.0 software (NCSS, LLC, Kaysville, UT, USA) was used to estimate the sample size. According to a meta-analysis by Kwok et al. [SPSS 25.0 statistical software (IBM Corporation, Arm... | PMC9941271 | ||
Results | PMC9941271 | |||
Recurrent ischemic stroke | GUSTO, bleeding, ischemic stroke | BLEEDING, ISCHEMIC STROKE | Within 90 days, 52 patients underwent recurrent ischemic stroke: 10 (7.87%) in the study group and 42 (20.60%) in the control group. The study group had a 62% lower risk of recurrent ischemic stroke than the control group (hazard ratio [HR] for the study group The primary outcome within 90 days*The bleeding was divided... | PMC9941271 |
Bleeding events | bleeding | EVENTS, BLEEDING | A total of 9 patients (7.09%) in the study group and 14 patients (6.86%) in the control group reported bleeding events. A Cox proportional hazards model revealed no significant difference between the two groups (HR, 1.019; 95% CI, 0.441–2.353; | PMC9941271 |
Statin-induced liver injury or SAM | None of the patients showed an increase superior to three-fold in the levels of ALT, AST, or CK. The ALT, AST, LDH, and CK levels remained stable before therapy and after 2 weeks (14 ± 3 days) among the groups (Comparison of various enzymology before and 2 weeks after medication (comparison of the levels of transaminas... | PMC9941271 | ||
Heterogeneity in reducing recurrent ischemic stroke among subgroups | atrial fibrillation, diabetes, AIS, ischemic stroke | RECURRENT CEREBRAL INFARCTION, HYPERLIPIDEMIA, ISCHEMIC STROKE, ATRIAL FIBRILLATION, HYPERTENSION, DIABETES | To explore the heterogeneity of the two different therapy regimens in reducing the risk of recurrent ischemic stroke for AIS patients within 90 days, we performed a subgroup analysis according to the aforementioned stratification. The intensive rosuvastatin therapy plus 7-day DAPT always effectively reduced the risk of... | PMC9941271 |
Discussion | thrombosis, bleeding, stroke, liver injury, neurological deficit, rupture, atrial fibrillation, platelet aggregation, diabetes | THROMBOSIS, BLEEDING, RECURRENCE, HYPERLIPIDEMIA, ADVERSE EVENTS, STROKE, PLAQUE, ATRIAL FIBRILLATION, HYPERTENSION, CEREBRAL INFARCTION, DIABETES | In this study, compared with rosuvastatin plus SAPT, the intensive rosuvastatin therapy plus 7-day DAPT significantly reduced the risk of recurrent stroke within 90 days for patients with mild to moderate AIS, without increasing adverse events, such as bleeding, statin-induced liver injury, or SAM. The reduction was pa... | PMC9941271 |
Limitations | This study was a single-center study with small sample size and incomplete randomized controlled design. These characteristics inevitably led to some weaknesses in the research results, which need to be confirmed by future large sample size and multi-center clinical studies. | PMC9941271 | ||
Conclusion | liver injury, diabetes, bleeding, ischemic stroke | BLEEDING, HYPERLIPIDEMIA, ISCHEMIC STROKE, HYPERTENSION, DIABETES | Compared with rosuvastatin plus SAPT, the intensive rosuvastatin therapy plus 7-day DAPT with aspirin and clopidogrel significantly reduced the risk of recurrent ischemic stroke within 90 days for patients with mild to moderate AIS, without increasing bleeding, statin-induced liver injury, or SAM. These effects were pa... | PMC9941271 |
Acknowledgements | We thank Ph.D Yunlei Wang for careful reading of the manuscript. | PMC9941271 | ||
Author contribution | Study conception or design: TZ and HTL. Acquisition of the data: TD, XML, JMC, XHY. Analysis and interpretation of the data: TD, WH, XML. Drafting and revising the article: TZ and HTL. All authors read and approved the final manuscript. | PMC9941271 | ||
Funding | This study was funded by Beijing Municipal Commission of Science and Technology (Grand Numbers: Z181100001718066). | PMC9941271 | ||
Data availability | All the required data about the study are present in the manuscript. We are happy to provide additional data if the reviewer or the editor requires further data. | PMC9941271 | ||
Declarations | PMC9941271 | |||
Ethical approval | The Medical Ethics Committee of China Rehabilitation Research Center has approved the study (Ethics approval number: 2018–022-1). Written informed consents were obtained from all participants. | PMC9941271 | ||
Conflict of interest | The authors declare no competing interests. | PMC9941271 | ||
References | PMC9941271 | |||
Methods | PMC10684334 | |||
Study design | This was a large, multinational case series of the performance of a single-use duodenoscope for ERCP. Institutional Review Board and Ethics Committee approvals for the study were obtained at all study sites. All enrolled patients provided written informed consent for study participation before they contributed data. Si... | PMC10684334 | ||
Single-use duodenoscope | STERILE |
The device used in this study was the EXALT Model D single-use duodenoscope (Boston Scientific Corporation), a sterile, single-use duodenoscope designed to function similarly to currently marketed reusable duodenoscopes, and to be discarded after use in a single procedure. The single-use duodenoscope received US FDA c... | PMC10684334 | |
Patient population | RECRUITMENT |
The study protocol allowed for recruitment of adult patients scheduled for ERCP per the standard of care at up to 40 participating healthcare centers. Eligible patients were recruited for the study on selected weekdays when participating endoscopists were performing ERCPs. Patients were eligible for inclusion if they ... | PMC10684334 | |
Study procedures | PMC10684334 | |||
Patient assessments | ADVERSE EVENTS | All enrolled participants had a preprocedural study visit for assessment of their demographics and relevant medical history. After the index procedure, participants were evaluated in person or by telephone at 72 hours (−1 day to + 2 days) and again at 30 days (± 3 days) to screen for post-procedure adverse events (AEs)... | PMC10684334 | |
ERCP procedures | Participating endoscopists agreed to use the single-use duodenoscope in place of other brands of duodenoscope(s) used in the endoscopy unit for ERCP. Endoscopists’ level of experience was categorized as “expert” (> 2000 lifetime ERCPs) and “less expert” (≤ 2000 lifetime ERCPs). Start and stop times of the procedure, po... | PMC10684334 | ||
Outcomes | SECONDARY | The primary end point was the ability to complete the ERCP procedures for the intended indication(s). The secondary end points were: (i) the incidence of crossover from the single-use duodenoscope to a reusable duodenoscope; (ii) comparison of outcomes by ASGE grade, endoscopist level of experience, or prior sphinctero... | PMC10684334 | |
Statistical analysis | Descriptive statistics included: frequency statistics for patient and procedural characteristics and procedure completion rates (completion rates reported separately for cases with and without crossover to a reusable duodenoscope); median and range for overall satisfaction and procedure duration; and mean (SD) and rang... | PMC10684334 | ||
Results | PMC10684334 | |||
Enrollment and patient characteristics |
Of 809 patients who were screened, 551 (68.1 %) were enrolled after providing written informed consent to participate in the study. Reasons for nonparticipation are summarized in
Patient flow through the study.
Of the 551 patients (mean age 59.9 years) who had a procedure, 281 (51.0 %) were male and 332 (60.3 %) had... | PMC10684334 | ||
Characteristics of the 551 patients who were entered into the study and underwent an ERCP procedure that began with a single-use duodenoscope. | cancer | CANCER, STRICTURE, BACTERIAL INFECTION | Older than 65 yearsIIIIIIIVVNot assessedBile duct stones/gallstones(current)Documented biliary or pancreatic stricture, unresolvedCurrent immunosuppression (any cause)Pharmacologically inducedPost-transplantPost-chemotherapy for cancer other than bile ductPost-chemotherapy for bile duct cancerDisease inducedIn preparat... | PMC10684334 |
General ERCP characteristics |
A total of 61 endoscopists (46 expert, 15 less expert) at 22 academic centers in 11 countries (1–6 endoscopists per center) performed 551 procedures: 25 cases at 21 of the study sites and 26 cases in the other. The median number of procedures performed by each endoscopist was seven (range 1–25). All procedures were pe... | PMC10684334 | ||
Characteristics of the 551 endoscopic procedures carried out. | sphincter of Oddi dysfunction, biliary stone, biliary leaks, divisum, pseudocyst, pancreatic stones, intrahepatic stones, tumors, pancreatic strictures, biliary strictures | RECURRENT PANCREATITIS, MINOR, SPHINCTER OF ODDI DYSFUNCTION, STRICTURES, TUMORS | PropofolOpioidNeuromuscular blockerInhalation agentEtomidateOtherPropofolOpioidSevofluraneBenzodiazepineNeuromuscular blockerOtherProneSupineLeft lateral decubitusEndoscopy suite
Difficult cannulation without failed ERCP
Failed ERCP without difficult cannulationFailed ERCP with difficult cannulationCompleted, no crosso... | PMC10684334 |
Cannulation details | Difficult CBD cannulation was reported for 150 /514 cases (29.2 %) using the single-use duodenoscope (10 of which were failed ERCPs), and in 15 cases in which a reusable duodenoscope was used after crossover.Advanced cannulation techniques performed included: precut (access) papillotomy (n = 42; 7.6 %), double wire (n ... | PMC10684334 | ||
Ability to complete ERCP for intended indication | DILATION |
Among the 551 study cases, 529 (96.0 %, 95 %CI 94.0 %–97.5 %) were completed for the intended indication, including 503 (91.3 %, 95 %CI 88.6 %–93.5 %) using only the single-use duodenoscope, and 26 (4.7 %, 95 %CI 3.1 %–6.8 %) including crossover from the single-use to a reusable duodenoscope. Of the 22 cases that were... | PMC10684334 |
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