MedTrace Logo

Comparing the Therapeutic Efficacy of Extended Isthmusectomy Versus Total Thyroidectomy for Isthmus Tumors of the Thyroid

NCT07274605 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2025-12-10

No results posted yet for this study

Summary

Prospective randomized open phase III non-inferiority trial in cT1bN0N1aM0 isthmus tumors of the thyroid comparing: extended Isthmusectomy (Isthmusectomy + Central Neck Dissection)(experimental group) versus total thyroidectomy + Central Neck Dissection (reference group).

Conditions

Interventions

PROCEDURE

Total thyroidectomy

Total Thyroidectomy with bilateral central compartment (level VI) neck dissection - surgical removal of entire thyroid gland and perform bilateral Level VI neck dissection. This is the standard treatment recommended by the Chinese Guidelines for the Diagnosis and Management of Thyroid Nodules and Differentiated Thyroid Cancer (2nd Edition). The participating surgeons all routinely perform complete central neck dissections. They were selected for this study due to their standardized technique, which ensures a consistent surgical approach.

PROCEDURE

Extended isthmusectomy

Extended isthmusectomy with bilateral central compartment (level VI) neck dissection : Completely resect the isthmus and portions of the bilateral thyroid gland adjacent to the isthmus, ensuring an R0 resection margin for the tumor, while preserving at least more than half of the bilateral thyroid lobes.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Zhiyu Li, MD · Thyroid surgery Department, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-19
Primary Completion
2028-11-01
Completion
2032-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07274605 on ClinicalTrials.gov