Selective Neck Dissection Versus Modified Neck Dissection in PTC

NCT ID: NCT06554652

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2029-06-30

Brief Summary

This study is a phase III, randomized controlled, open label non inferiority study. Patients who meet the inclusion criteria are randomly assigned 1:1 to either the experimental group (selective neck dissection) or the control group (modified neck dissection), with LRFS as the primary endpoint. The aim of the study is to evaluate the safety of selective neck dissection in papillary carcinoma with limited number of lymph node metastases in the lateral neck, and the quality of life compared with modified neck dissection.

Conditions

Thyroid Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Selective neck dissection

Group Type: EXPERIMENTAL

Lymph node tracer navigated selective neck dissection

Intervention Type: PROCEDURE

Selective lateral lymph node dissection (after injection of tracer, lymph nodes in compartment III-IV are dissected; if there is dyed lymph node in compartment IIA, then IIA is dissected).

Modified neck dissection

Group Type: ACTIVE_COMPARATOR

Modified neck dissection

Intervention Type: PROCEDURE

Lymph nodes in compartment IIA, IIB, III, IV, VB are dissected.

Interventions

Lymph node tracer navigated selective neck dissection

Selective lateral lymph node dissection (after injection of tracer, lymph nodes in compartment III-IV are dissected; if there is dyed lymph node in compartment IIA, then IIA is dissected).

Intervention Type: PROCEDURE

Modified neck dissection

Lymph nodes in compartment IIA, IIB, III, IV, VB are dissected.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Pathologically confirmed PTC;
• Age range: 14-80 years old;
• Preoperative fine needle aspiration confirms lymph node metastasis in the lateral neck
• Ultrasound and CT suggest that metastatic/suspected metastatic lymph nodes are limited to compartment IV, with 1-2 lymph node metastases and <1cm in short diameter. The lymph nodes have no central necrosis, liquefaction, peripheral enhancement, or disappearance of adjacent fat spaces (predicting unobstructed lymphatic vessels);
• Thyroid tumors without extra thyroidal extension;
• Enough thyroid volume to inject tracer.

Exclusion Criteria

• Previous neck surgery;
• Bilateral neck lymph node dissection;
• Distant metastases;
• High risk pathological subtypes or the presence of other high-risk factors for recurrence;
• Previous treatment for thyroid cancer other than endocrine therapy;
• The patient is unable to cooperate with follow-up.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Yu Wang

Chief of Head and Neck Surgery, Fudan University Shanghai Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan Univeristy Shanghai Cancer Center

Shanghai, , China

Countries

China

Other Identifiers

SELECTION

Identifier Type: -

Identifier Source: org_study_id