Clinical trial · Interventional
Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer
Thyroid Gland Removal With or Without Central Lymph Node Dissection in Treating Patients With Node Negative Thyroid Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial studies how well thyroid gland removal with or without central lymph node dissection works in treating patients with thyroid cancer or suspected thyroid cancer that has not spread to the lymph nodes (randomized into Arms I and II). Arms I and II are compared to a standard of care (SOC) Arm III to enable comparison of quality of life among various surgical treatments. Currently, the standard treatment for thyroid cancer is total thyroidectomy, or complete removal of the thyroid. The lymph nodes in the central part of the neck may also be surgically removed, called central lymph node dissection. Prophylactic removal of the lymph nodes may increase the risk of life-threatening complications, and may reduce post-surgery quality of life. It may also prevent the cancer from returning and reduce the need for additional surgery. It is not yet known whether recurrence rates and complication levels are lower after thyroid gland removal alone or with central lymph node dissection.
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 |
|---|---|---|---|
| Stage III Papillary Thyroid Cancer | Thyroid Gland Papillary Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Papillary Thyroid Cancer | Thyroid Gland Papillary Carcinoma | CURATED_BROADER | 0.78 |
| Stage I Papillary Thyroid Cancer | Thyroid Gland Papillary Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| entral lymph node dissection (CLND) | Procedure | — | UNRESOLVED |
| Quality-of-life assessment | Other | — | UNRESOLVED |
| Thyroidectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I (no CND)
- description
- Patients undergo total thyroidectomy alone.
- interventionNames
- Procedure: Thyroidectomy
- Other: Quality-of-life assessment
- type
- EXPERIMENTAL
- label
- Arm II (CND)
- description
- Patients undergo total thyroidectomy with ipsilateral prophylactic CND.
- interventionNames
- Procedure: Thyroidectomy
- Procedure: entral lymph node dissection (CLND)
- Other: Quality-of-life assessment
- type
- ACTIVE_COMPARATOR
- label
- Arm III (SOC)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 73 Years
Show eligibility criteria text
Inclusion Criteria: * Pre-operative diagnosis or suspicion of papillary thyroid cancer, usually by fine needle aspiration (FNA) * No pre-operative evidence of cervical lymph node metastases on neck ultrasound (randomization arms only) * No evidence of distant metastases * Ability to read and write in English Exclusion Criteria: * Largest papillary thyroid carcinoma \< 1 cm in size on ultrasound * Previous thyroid surgery * Concurrent active malignancy of another type * Inability to give informed consent or lacks decision making capacity * T4 tumor * Pre-existing vocal cord paralysis * Chronic neurologic condition which affects voice or swallow (for instance, multiple sclerosis or Parkinson disease) * Baseline laryngeal pathology that would warrant intervention that could affect voice or swallow function * Becomes pregnant before surgery or at any time while on study INTRA-OPERATION EXCLUSION CRITERIA (randomization arms only) * Evidence of nodal involvement identified in the operating room (OR) * Failure to confirm diagnosis of cancer in participant
References
Publications (3)
- DERIVEDKnigge MA, Robbins D, Thibeault S, Connor N, Sippel R. Secondary analyses of swallowing efficiency and safety outcomes following thyroidectomy versus thyroidectomy plus prophylactic central neck dissection. Thyroid Res. 2025 Sep 16;18(1):45. doi: 10.1186/s13044-025-00264-5. PMID 40954474
- DERIVEDSippel RS, Robbins SE, Poehls JL, Pitt SC, Chen H, Leverson G, Long KL, Schneider DF, Connor NP. A Randomized Controlled Clinical Trial: No Clear Benefit to Prophylactic Central Neck Dissection in Patients With Clinically Node Negative Papillary Thyroid Cancer. Ann Surg. 2020 Sep 1;272(3):496-503. doi: 10.1097/SLA.0000000000004345. PMID 33759836
- DERIVEDKletzien H, Macdonald CL, Orne J, Francis DO, Leverson G, Wendt E, Sippel RS, Connor NP. Comparison Between Patient-Perceived Voice Changes and Quantitative Voice Measures in the First Postoperative Year After Thyroidectomy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Nov 1;144(11):995-1003. doi: 10.1001/jamaoto.2018.0309. PMID 29710208