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Microcalcifications 5–69 93–100
Cystic aspect 10–34 91–100
Peripheral vascularity 40–86 57–93
Hyperechogenicity 30–87 43–95
Round shape 37 70 | 193 |
aAdapted with permission from the European Thyroid Associa- tion guidelines for cervical ultrasound (20). | 194 |
cancer risk. However, given the higher pretest likelihood of thyroid cancer associated with these clinical risk factors, FNA can be considered at lower size cutoffs for all of the sonographic appearances described above.
Ultrasound elastography (USE) has similarly been investi- gated for its ability to modify thyroid c... | 195 |
[A11] What is the role of FNA, cytology interpretation, and molecular testing in patients with thyroid nodules? | 196 |
RECOMMENDATION 9
Thyroid nodule FNA cytology should be reported using diagnostic groups outlined in the Bethesda System for Reporting Thyroid Cytopathology.
(Strong recommendation, Moderate-quality evidence) | 197 |
To address a significant variability in the reporting of cy- tological findings in thyroid FNA samples, the 2007 National Cancer Institute Thyroid Fine-Needle Aspiration State of the Science Conference provided consensus recommenda- tions known as the Bethesda System for Reporting Thyroid Cytopathology (99,100). The Be... | 198 |
Diagnostic category
Table 8. The Bethesda System for Reporting Thyroid Cytopathology: Diagnostic Categories and Risk of Malignancya
Estimated/predicted risk of malignancy by the Bethesda system, %a | 202 |
Actual risk of malignancy in nodules surgically excised,
% median (range)b | 204 |
Nondiagnostic or unsatisfactory 1–4 20 (9–32)
Benign 0–3 2.5 (1–10) | 206 |
Atypia of undetermined significance or follicular lesion of undetermined significance
5–15 14 (6–48) | 207 |
aAs reported in The Bethesda System by Cibas and Ali (1076).
bBased on the meta-analysis of eight studies reported by Bongiovanni et al. (103). The risk was calculated based on the portion of nodules in each diagnostic category that underwent surgical excision and likely is not representative of the entire population, ... | 208 |
opinion (Fig. 1, Table 8). These categories are (i) nondiagnostic/ unsatisfactory; (ii) benign; (iii) atypia of undetermined signifi- cance/follicular lesion of undetermined significance (AUS/ FLUS); (iv) follicular neoplasm/suspicious for follicular neo- plasm (FN/SFN), a category that also encompasses the diag- nosis... | 210 |
[A12] Nondiagnostic cytology | 211 |
RECOMMENDATION 10
For a nodule with an initial nondiagnostic cytology result, FNA should be repeated with US guidance and, if available, on-site cytologic evaluation
(Strong recommendation, Moderate-quality evidence)
Repeatedly nondiagnostic nodules without a high suspicion sonographic pattern require close observat... | 212 |
Nondiagnostic or unsatisfactory FNA biopsies are those that fail to meet the established quantitative or qualitative
criteria for cytologic adequacy (i.e., the presence of at least
six groups of well-visualized follicular cells, each group
containing at least 10 well-preserved epithelial cells, pref-
erably on a sin... | 213 |
[A13] Benign cytology | 214 |
RECOMMENDATION 11
If the nodule is benign on cytology, further immediate diagnostic studies or treatment are not required
(Strong recommendation, High-quality evidence) | 215 |
Accurate FNA cytology diagnosis depends upon a num- ber of factors including the skill of the operator, FNA tech- nique, specimen preparation, and cytology interpretation. | 216 |
Ultrasound-guided FNA with real-time visualization of needle placement in the target nodule decreases the false-negative rate of a benign cytology diagnosis (68,69,126,128). Although pro- spective studies are lacking, malignancy rates of only 1%–2% have been reported in large retrospective series that analyzed the util... | 218 |
[A14] Malignant cytology | 219 |
RECOMMENDATION 12
If a cytology result is diagnostic for primary thyroid ma- lignancy, surgery is generally recommended.
(Strong recommendation, Moderate-quality evidence) | 220 |
A cytology diagnostic for a primary thyroid malignancy will almost always lead to thyroid surgery. However, an ac-
tive surveillance management approach can be considered as
an alternative to immediate surgery in
patients with very low risk tumors (e.g., papillary microcarcinomas without clinically evident metasta- s... | 221 |
of PTMC patients destined to develop clinically significant progression from the larger population of people that harbor indolent PTMCs that will not cause significant disease.
Similarly, well-known thyroid cancer oncogenes, such as
BRAF, when taken in isolation, are not able to specifically
identify the microcarcino... | 223 |
[A15] Indeterminate cytology (AUS/FLUS, FN, SUSP)* | 224 |
[A16] What are the principles of the molecular testing of FNA samples?
Molecular markers may be classified according to intended use; that is, diagnostic (classification of a disease state), prognostic, or predictive purposes (providing information on the estimated probability of therapeutic benefit or harm of a specif... | 225 |
RECOMMENDATION 13
If molecular testing is being considered, patients should be
counseled regarding the potential benefits and limitations of testing and about the possible uncertainties in the therapeutic and long-term clinical implications of results.
(Strong recommendation, Low-quality evidence) | 226 |
The largest studies of preoperative molecular markers in patients with indeterminate FNA cytology have respectively evaluated a seven-gene panel of genetic mutations and re- arrangements (162), | 227 |
a gene expression classifier (167 GEC; mRNA expression
of 167 genes) (163), and galectin-3 immunohistochemistry | 228 |
*The final draft for the sections (A15–A19) and recommenda- tions (13–17) were revised and approved by a subgroup of seven members of the task force with no perceived conflicts or competing interests in this area.
{From the NCCN Biomarkers Compendium (www.nccn.org/ professionals/biomarkers/default.aspx).
(cell blocks) ... | 229 |
and PPV (84%–100%) (105,122,162,165–168). Although
BRAFV600E single mutation testing has been estimated to have a specificity of approximately 99% (pooled data from 1117 nodules with histopathologic confirmation from multiple studies), the sensitivity has been deemed to be too low to reliably rule out the presence of m... | 231 |
RECOMMENDATION 14
If intended for clinical use, molecular testing should be per- formed in Clinical Laboratory Improvement Amendments/ College of American Pathologists (CLIA/CAP)-certified molecular laboratories, or the international equivalent, | 232 |
because reported quality assurance practices may be superior compared to other settings.
(Strong recommendation, Low-quality evidence) | 234 |
Many molecular marker tests are available in hospital-based molecular pathology laboratories and in reference laboratories. Importantly, all molecular marker tests intended for clinical use should be performed only in CLIA/CAP-certified molecular laboratories after appropriate analytical and clinical validation of all ... | 235 |
[A17] AUS/FLUS cytology | 236 |
RECOMMENDATION 15
For nodules with AUS/FLUS cytology, after consider- ation of worrisome clinical and sonographic features, in- vestigations such as repeat FNA or molecular testing may be used to supplement malignancy risk assessment in lieu of proceeding directly with a strategy of either surveillance or diagnostic su... | 237 |
Based on the Bethesda System, this diagnostic category is reserved for specimens that contain cells with architectural and/or nuclear atypia that is more pronounced than expected for benign changes but not sufficient to be placed in one of the higher risk diagnostic categories (99,190). Although this diagnostic categor... | 238 |
(200). In three other recent studies, there were insufficient data for analysis in the AUS/FLUS subgroup to draw any mean- ingful conclusion on 167 GEC test performance in that sub- group (172–174). In addition, published follow-up for the 167 GEC is currently limited to a mean of 8.5 months in a subgroup of 71 patient... | 240 |
[A18] Follicular neoplasm/suspicious for follicular neo- plasm cytology | 241 |
RECOMMENDATION 16
Diagnostic surgical excision is the long-established standard of care for the management of FN/SFN cytology nodules. However, after consideration of clinical and
sonographic features, molecular testing may be used to supplement malignancy risk assessment data in lieu of proceeding directly with surger... | 242 |
This diagnostic category of the Bethesda System is used for cellular aspirates (i) comprised of follicular cells arranged in an altered architectural pattern characterized by cell crowding and/or microfollicle formation and lacking nuclear features of papillary carcinoma or (ii) comprised almost ex- clusively of oncocy... | 243 |
15% (4 of 27), and NPV 75% (three of four) (173). In a single- center retrospective study including 64 nodules subjected to 167 GEC testing and a cytology read as FN/FN with oncocytic features, the PPV for a suspicious GEC result was 37% (11 of 30), although the PPV was significantly higher in the FN group (53%) compar... | 245 |
[A19] Suspicious for malignancy cytology | 246 |
RECOMMENDATION 17
If the cytology is reported as suspicious for papillary carcinoma (SUSP), surgical management should be simi- lar to that of malignant cytology, depending on clinical risk factors, sonographic features, patient preference, and possibly results of mutational testing (if performed).
(Strong recommendati... | 247 |
This diagnostic category of the Bethesda System is reserved for aspirates with cytologic features that raise a strong suspi- cion for malignancy (mainly for PTC) but are not sufficient for a conclusive diagnosis (99,209). This is the highest risk cate- gory of indeterminate cytology in the Bethesda System, with an esti... | 248 |
[A20] What is the utility of 18FDG-PET scanning to predict malignant or benign disease when FNA cytology is indeterminate (AUS/FLUS, FN, SUSP)? | 249 |
RECOMMENDATION 18
18FDG-PET imaging is not routinely recommended for the evaluation of thyroid nodules with indeterminate cytology.
(Weak recommendation, Moderate-quality evidence) | 250 |
Eight studies have been performed and are the subject of two meta-analyses (213–222). While early data suggested a high NPV for 18FDG-PET in this setting, most studies failed to use the Bethesda System for Reporting Thyroid Cyto- pathology and included numerous small nodules <1 cm in diameter (221). A recent meta-analy... | 251 |
[A21] What is the appropriate operation
for cytologically indeterminate thyroid nodules? | 252 |
RECOMMENDATION 19
When surgery is considered for patients with a solitary, cytologically indeterminate nodule, thyroid lobectomy is the recommended initial surgical approach. This approach
may be modified based on clinical or sonographic char- acteristics, patient preference, and/or molecular testing when performed (s... | 253 |
RECOMMENDATION 20
Because of increased risk for malignancy, total
thyroidectomy may be preferred in patients with indeter-
minate nodules that are cytologically suspicious for ma- lignancy, positive for known mutations specific for carcinoma, sonographically suspicious, or large (>4 cm), or in patients with fami... | 254 |
recommended based on the indeterminate nodule being malignant following lobectomy.
(Strong recommendation, Moderate-quality evidence)
Patients with indeterminate nodules who have bilateral nodular disease, those with significant medical co- morbidities, or those who prefer to undergo bilateral thy- roidectomy to avoid ... | 256 |
The primary goal of thyroid surgery for a thyroid nodule that is cytologically indeterminate (AUS/FLUS or FN or SUSP) is to establish a histological diagnosis and definitive removal, while reducing the risks associated with remedial surgery in the previously operated field if the nodule proves to be malignant. Surgical... | 257 |
subsequent completion thyroidectomy versus initial total thyroidectomy. | 259 |
[A22] How should multinodular thyroid glands (i.e., two or more clinically relevant nodules) be evaluated for malignancy? | 260 |
RECOMMENDATION 21
Patients with multiple thyroid nodules ‡1 cm should be evaluated in the same fashion as patients with a solitary nodule ‡1 cm, excepting that each nodule that is >1 cm carries an independent risk of malignancy and therefore multiple nodules may require FNA.
(Strong recommendation, Moderate-quality ... | 261 |
RECOMMENDATION 22
A low or low-normal serum TSH concentration in patients with multiple nodules may suggest that some nodule(s) may be autonomous. In such cases, a radionuclide (pref- erably 123I) thyroid scan should be considered and directly compared to the US images to determine functionality of each nodule ‡1 cm. F... | 262 |
Patients with multiple thyroid nodules have the same risk of malignancy as those with solitary nodules (32,74). How- ever, when evaluating the risk of cancer per individual nod- ule, one large study found that a solitary nodule had a higher likelihood of malignancy than did a nonsolitary nodule ( p < 0.01), alth... | 263 |
[A23] What are the best methods for long-term follow-up of patients with thyroid nodules?
[A24] Recommendations for initial follow-up of nodules with benign FNA cytology | 264 |
RECOMMENDATION 23
Given the low false-negative rate of US-guided FNA cy- tology and the higher yield of missed malignancies based upon nodule sonographic pattern rather than growth, the
follow-up of thyroid nodules with benign cytology diag- noses should be determined by risk stratification based
upon US pattern.
No... | 265 |
[A25] Recommendation for follow-up of nodules with two benign FNA cytology results
If a nodule has undergone repeat US-guided FNA with a second benign cytology result, US surveillance for this nod- ule for continued risk of malignancy is no longer indicated.
(Strong recommendation, Moderate-quality evidence)
Given t... | 266 |
nodule size, which is equivalent to a 20% increase in two of the three nodule dimensions. If a 50% volume increase cutoff is applied, only 4%–10% of nodules were reported to be larger at a mean of 18 months (133,238). However, using cutoffs of a 15% volume increase based upon inter- nally assessed interobserver coeffic... | 268 |
[A26] Follow-up for nodules that do not meet FNA criteria | 269 |
RECOMMENDATION 24
Nodules may be detected on US that do not meet criteria for FNA at initial imaging (Recommendation 8). The strategy for sonographic follow-up of these nodules should be based upon the nodule’s sonographic pattern.
Nodules with high suspicion US pattern: repeat US in 6–12 months.
(Weak recommendation, ... | 270 |
Ultrasound studies demonstrate that up to 50% of adults have thyroid nodules. The vast majority of these are subcentimeter, and FNA evaluation is generally not indicated. In addition, based upon both sonographic pattern and size cutoffs (Re- commendation 8), many nodules >1 cm may also be followed without FNA. Although... | 271 |
unlikely to change during 5-year sonographic follow-up, and the risk of malignancy is exceedingly low. The findings from studies correlating sonographic features and malignancy risk in aspirated nodules can be extrapolated to inform a follow-up strategy for this group of nodules that do not meet FNA criteria at the tim... | 273 |
[A27] What is the role of medical or surgical therapy for benign thyroid nodules? | 274 |
RECOMMENDATION 25
Routine TSH suppression therapy for benign thyroid nod- ules in iodine sufficient populations is not recommended. Though modest responses to therapy can be detected, the potential harm outweighs benefit for most patients.
(Strong recommendation, High-quality evidence) | 275 |
RECOMMENDATION 26
Individual patients with benign, solid, or mostly solid nodules should have adequate iodine intake. If inadequate dietary intake is found or suspected, a daily supplement (containing 150 lg iodine) is recommended.
(Strong recommendation, Moderate-quality evidence) | 276 |
RECOMMENDATION 27
Surgery may be considered for growing nodules that are benign after repeat FNA if they are large (>4 cm), causing compressive or structural symptoms, or based upon clinical concern.
(Weak recommendation, Low-quality evidence)
Patients with growing nodules that are benign after FNA should be regularly... | 277 |
RECOMMENDATION 28
Recurrent cystic thyroid nodules with benign cytology should be considered for surgical removal or percutaneous ethanol injection (PEI) based on compressive symptoms and cosmetic concerns. Asymptomatic cystic nodules may be followed conservatively.
(Weak recommendation, Low-quality evidence) | 278 |
RECOMMENDATION 29
There are no data to guide recommendations on the use of thyroid hormone therapy in patients with growing nodules that are benign on cytology.
(No recommendation, Insufficient evidence)
Evidence from multiple prospective, RCTs, and from three meta-analyses suggest that thyroid hormone supplementation
... | 279 |
[A28] How should thyroid nodules in pregnant
women be managed?
[A29] FNA for thyroid nodules discovered during preg- nancy | 280 |
RECOMMENDATION 30
FNA of clinically relevant thyroid nodules (refer to section [A10]) should be performed in euthyroid and hy-
pothyroid pregnant women.
(Strong recommendation, Moderate-quality evidence)
For women with suppressed serum TSH levels that persist beyond 16 weeks gestation, FNA may be deferred until af... | 281 |
time, a radionuclide scan can be performed to evaluate nodule function if the serum TSH remains suppressed.
(Strong recommendation, Moderate-quality evidence) | 283 |
It is uncertain if thyroid nodules discovered in pregnant
women are more likely to be malignant than those found in
nonpregnant women, since there are no population-based studies to address this question. Pregnancy does not appear to
modify microscopic cellular appearance, thus standard diag- nostic criteria should ... | 284 |
[A30] Approaches to pregnant patients with malignant or indeterminate cytology | 285 |
RECOMMENDATION 31
PTC discovered by cytology in early pregnancy should be monitored sonographically. If it grows substantially (as defined in section [A24]) before 24–26 weeks ges-
tation, or if US reveals cervical lymph nodes that are suspicious for metastatic disease, surgery should be
considered during pregn... | 286 |
If FNA cytology is consistent with PTC, surgery is gener- ally recommended. However, the decision to perform such surgery either during pregnancy or after delivery must be individualized. If surgery is not performed, the utility of
thyroid hormone therapy targeted to lower serum TSH levels to improve the prognosis... | 287 |
[B1] DIFFERENTIATED THYROID CANCER: INITIAL MANAGEMENT GUIDELINES
Differentiated thyroid cancer, arising from thyroid follic- ular epithelial cells, accounts for the vast majority of thyroid cancers. Of the differentiated cancers, papillary cancer comprises about 85% of cases compared to about 12% that have follicular ... | 288 |
differentiated tumors (268). In general, stage for stage, the prognoses of PTC and follicular cancer are similar (266,269). | 290 |
[B2] Goals of initial therapy of DTC
The basic goals of initial therapy for patients with DTC are to improve overall and disease-specific survival, reduce the
risk of persistent/recurrent disease and associated morbidity,
and permit accurate disease staging and risk stratification,
while minimizing treatment-related... | 291 |
[B3] What is the role of preoperative staging with diagnostic imaging and laboratory tests?
[B4] Neck imaging—ultrasound | 292 |
RECOMMENDATION 32
Preoperative neck US for cervical (central and especially lateral neck compartments) lymph nodes is recommended for all patients undergoing thyroidectomy for malignant or suspicious for malignancy cytologic or molecular findings.
(Strong recommendation, Moderate-quality evidence)
US-guided FNA of... | 293 |
Differentiated thyroid carcinoma (particularly papillary car- cinoma) involves cervical lymph node metastases in 20%–50% of patients in most series using standard pathologic techniques (84,145,281–283), and it may be present even when the primary tumor is small and intrathyroidal (284). The frequency of mi- crometastas... | 294 |
FIG. 3. Lymph node compartments separated into levels and sublevels. Level VI contains the thyroid gland, and the adjacent nodes bordered superiorly by the hyoid bone, inferiorly by the innominate (brachiocephalic) artery, and laterally on each side by the carotid sheaths. The level II, III, and IV nodes are arrayed al... | 296 |
a large lymph node with microcalcifications) (300). In a retrospective study of 241 lymph nodes in 220 patients who underwent US-guided FNA with Tg in FNA (FNA-Tg) washout fluid measurements for suspicious lymph nodes, additional FNA-Tg helped to diagnose a metastatic lymph node with one or two suspicious US features b... | 297 |
[B5] Neck imaging—CT/MRI/PET | 298 |
RECOMMENDATION 33
Preoperative use of cross-sectional imaging studies (CT, MRI) with intravenous (IV) contrast is recommended as an adjunct to US for patients with clinical suspicion for
advanced disease, including invasive primary tumor, or clinically apparent multiple or bulky lymph node involve- ment.
(Strong recom... | 299 |
Since US evaluation is operator dependent and cannot al- ways adequately image deep anatomic structures and those acoustically shadowed by bone or air, alternative imaging procedures may be preferable or useful as an adjunct in | 300 |
some clinical settings. Patients displaying bulky or widely distributed nodal disease on initial US examination may present with involvement of nodal regions beyond typical cervical regions, some of which maybe difficult to visualize on routine preoperative US, including the mediastinum, infra- clavicular, retropharyng... | 302 |
[B6] Measurement of serum Tg and anti-Tg antibodies | 303 |
RECOMMENDATION 34
Routine preoperative measurement of serum Tg or anti-Tg antibodies is not recommended.
(Weak recommendation, Low-quality evidence) | 304 |
Data from a systematic review and meta-analysis sug- gested that high preoperative concentrations of serum Tg may predict a higher sensitivity for postoperative surveil- lance with serum Tg (316). Preoperative anti-Tg antibodies do not appear to be an independent preoperative predictor of stage in patients with DTC, bu... | 305 |
[B7] Operative approach for a biopsy diagnostic for follic- ular cell–derived malignancy | 306 |
RECOMMENDATION 35
For patients with thyroid cancer >4 cm, or with gross extrathyroidal extension (clinical T4), or clinically appar- ent metastatic disease to nodes (clinical N1) or distant sites (clinical M1), the initial surgical procedure should include a near-total or total thyroidectomy and gross removal of all pr... | 307 |
(lobectomy). Thyroid lobectomy alone may be sufficient initial treatment for low-risk papillary and follicular car- cinomas; however, the treatment team may choose total thyroidectomy to enable RAI therapy or to enhance follow- up based upon disease features and/or patient preferences.
(Strong recommendation, Moderat... | 309 |
Surgery for thyroid cancer is an important element of a multifaceted treatment approach. The operation must be compatible with the overall treatment strategy and follow-up plan recommended by the managing team. Consideration should be given to referring patients with high-risk features (clinical N1 disease, concern for... | 310 |
Consistent with the SEER data analyses, two single-center studies also confirmed that lobectomy is associated with excellent survival in properly selected patients (322,326). After a median follow-up of 8 years, only one disease- specific death was seen in a cohort of 889 PTC patients with T1–T2 tumors treated with e... | 312 |
[B8] Lymph node dissection | 313 |
RECOMMENDATION 36
Therapeutic central-compartment (level VI) neck dissection for patients with clinically involved central nodes should accompany total thyroidectomy to provide clearance of disease from the central neck.
(Strong recommendation, Moderate-quality evidence)
Prophylactic central-compartment neck dissection... | 314 |
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