Clinical trial · Interventional
Total Thyroidectomy With and Without Prophylactic Central Neck Lymph Node Dissection in People With Low-risk Papillary Thyroid Cancer
Randomized Controlled Trial of Total Thyroidectomy With and Without Prophylactic Central Neck Lymph Node Dissection in Patients With Low-risk Papillary Thyroid Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow/Insufficient accrual
Summary
Brief summary (as posted)
Background: \- Papillary thyroid cancer (PTC) often spreads to lymph nodes in the neck. This can be hard to detect. People often have lymph nodes removed anyway, and researchers want to study if this is a good idea. Objective: \- To compare the effectiveness of removing lymph nodes in the neck that show no evidence of cancer along with the thyroid, or removing only the thyroid. Eligibility: \- Adults age 18 and older with PTC or thyroid nodules suspicious for PTC, with no evidence that the disease has spread in the body. Design: * Participants will be screened with medical history, physical exam, blood tests, scans, and x-rays. * Participants will: * Answer questions. They may have a tumor biopsy. * Have a flexible laryngoscopy. A small tube will pass through the nose to the vocal cords. * Group 1: have surgery to remove the thyroid gland only. Lymph nodes in the neck will be removed if the cancer has spread. * Group 2: have surgery to remove the thyroid and lymph nodes in the neck. * At all post-surgery visits, participants will answer questions and have blood drawn. In addition: * 1 day: laryngoscopy. * 2 weeks: possible laryngoscopy. * 3 months: ultrasound of the thyroid and neck. * Discuss whether to try hormone treatment and/or radioactive iodine. * Possible diagnostic whole body radioiodine scan (WBS). Participants will swallow a capsule or liquid and lie under a camera. * 6 months: ultrasound and maybe laryngoscopy. * 1 year: diagnostic WBS and ultrasound. Participants may get thyroid stimulating hormone. * Participants will have annual follow-up visits for 10 years. They will have a physical exam, blood drawn, scans, and may complete a questionnaire.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endocrine Malignancy | — | UNRESOLVED | — |
| Low-risk Papillary Thyroid Cancer | — | UNRESOLVED | — |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic central neck lymph node dissection (pCND) | Procedure | — | UNRESOLVED |
| Total Thyroidectomy (TT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND)
- description
- TT plus pCND
- interventionNames
- Procedure: Total Thyroidectomy (TT)
- Procedure: Prophylactic central neck lymph node dissection (pCND)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1/Total Thyroidectomy (TT) alone
- description
- TT alone
- interventionNames
- Procedure: Total Thyroidectomy (TT)
Primary outcomes (1)
- measure
- Number of Participants That Have Biochemical Cure After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * Patients must have histologically or cytologically confirmed at least 1 thyroid nodule that is greater than or equal to1 cm. but less than or equal to 4 cm measured in greatest dimension and confirmed by the Laboratory of Pathology, National Cancer Institute (NCI) or confirmed by the pathology laboratory of the enrolling institution: * Indeterminate thyroid biopsy per Bethesda System for reporting thyroid cytopathology with B-Raf Proto-oncogene Serine/Threonine Kinase (BRAF) Valine 600 Glutamic Acid (V600E) mutation or rearranged in transformation/papillary thyroid carcinomas (RET/PTC) rearrangement * Cytologically or histologically suspicious or confirmed PTC per Bethesda System for reporting thyroid cytopathology. * Age greater than or equal to 18 years. Because PTC occurs rarely in patients \<18 years of age, children are excluded from this study. * Absence of radiographic evidence of extrathyroidal extension. * Absence of abnormal lymphadenopathy suggesting metastatic PTC on physical examination and/or imaging studies. * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Patients must have adequate organ function to safely undergo general anesthesia and thyroidectomy. Laboratory values obtained less than or equal to 4 weeks prior to surgery must demonstrate adequate bone marrow function (hemoglobin (Hb) greater than or equal to 6.0 mmol/L, absolute neutrophil count greater than or equal to 1.5 x 10\^9/L, platelets greater than or equal to 80 x 10\^9/L), liver function (serum bilirubin less than or equal to 2 x upper limit of normal (ULN), serum transaminases less than or equal to 3 x ULN). Patients with chronic kidney disease who are on chronic renal replacement therapy are allowed. Other tests, such as pulmonary function tests, cardiac echocardiogram or stress test, will be performed if clinically indicated. * Ability of subject to understand and the willingness to sign a written informed consent document. * Women must not become pregnant prior to surgery or during the first 3 months after surgery. Women who can become pregnant will be asked to practice an effective form of birth control for up to 3 months after surgery. EXCLUSION CRITERIA: * Patients who have had previous thyroid surgery * Patients whose tumors are deemed unresectable by clinical/imaging criteria. * Patients with known synchronous distant metastatic disease. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded because we do not want to expose the unborn child to the procedures necessary to perform the surgery.
References
Publications (3)
- BACKGROUNDLang BH, Wong KP, Wan KY, Lo CY. Significance of metastatic lymph node ratio on stimulated thyroglobulin levels in papillary thyroid carcinoma after prophylactic unilateral central neck dissection. Ann Surg Oncol. 2012 Apr;19(4):1257-63. doi: 10.1245/s10434-011-2105-5. Epub 2011 Oct 12. PMID 21989667
- BACKGROUNDIyer NG, Morris LG, Tuttle RM, Shaha AR, Ganly I. Rising incidence of second cancers in patients with low-risk (T1N0) thyroid cancer who receive radioactive iodine therapy. Cancer. 2011 Oct 1;117(19):4439-46. doi: 10.1002/cncr.26070. Epub 2011 Mar 22. PMID 21432843
- BACKGROUNDLee J, Kwon IS, Bae EH, Chung WY. Comparative analysis of oncological outcomes and quality of life after robotic versus conventional open thyroidectomy with modified radical neck dissection in patients with papillary thyroid carcinoma and lateral neck node metastases. J Clin Endocrinol Metab. 2013 Jul;98(7):2701-8. doi: 10.1210/jc.2013-1583. Epub 2013 May 15. PMID 23678034