Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the prophylactic ipsilateral central lymph node dissection is equally effective in the management of papillary thyroid microcarcinoma(PTMC) to the bilateral central lymph node dissection.

Detailed Description
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The extent, the advantage and disadvantage of prophylactic central lymph node dissection was not fully established up to now in papillary thyroid microcarcinoma. Prophylactic bilateral central lymph node dissection can give a important clinical information about the status of lymph nodes, and possibly guide a further adjuvant treatment. However, it causes high postoperative morbidity, including hypocalcemia and hoarseness. In this respect, some advocate no central lymph node dissection in prophylactic settings. Thus, we aimed to prove the efficacy of prophylactic ipsilateral central lymph node dissection in thyroid papillary microcarcinoma, compared to the bilateral dissection and no dissection. Type of Study design: Prospective randomized, controlled double-blinded (to subjects and observers) study. Group I: Limited/ipsilateral central lymph node dissection (UniCND) Group II: Comprehensive/bilateral central lymph node dissection (BiCND) Group III: No central lymph node dissection (NoCND) Outcomes: vocal cord palsy, hypocalcemia, locoregional recurrence, distant metastasis

Official Title
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Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma: A Prospective Randomized Controlled Trial

Conditions
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Thyroid Cancer

Intervention / Treatment
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* Procedure: Prophylactic central lymph node dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 to 70 Sonographically node-negative cytology confirmed thyroid papillary carcinoma Tumor size less than 1 cm in sonography Tumor confined to the one lobe of the thyroid gland One who provides the informed consent Exclusion Criteria: History of radiation treatment to head and neck area History of other malignancy except thyroid cancer Poor performance status (ECOG 3-4)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UniCND<br>Limited/ipsilateral central lymph node dissection | Procedure: Prophylactic central lymph node dissection<br>* prophylactic ipsilateral versus bilateral central lymph node dissection<br>|
| Active Comparator: BiCND<br>Comprehensive/bilateral central lymph node dissection | Procedure: Prophylactic central lymph node dissection<br>* prophylactic ipsilateral versus bilateral central lymph node dissection<br>|
| No Intervention: NoCND<br>No central lymph node dissection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools) |  | 3 year after initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications(hypocalcemia, hoarseness) |  | up to 3 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Papillary thyroid carcinoma, Lymph node dissection, Lymph node metastasis, Prophylactic node dissection, Central lymph node metastasis