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

NCT07274605 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Phase

Not applicable

Started

2025-12-19

Last updated

2025-12-10

Condition(s) studied

ThymectomyThyroid Cancer

Investigational drug(s) / intervention(s)

Total thyroidectomyExtended isthmusectomy

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.

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.

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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: \- Age 18 years or older. Diagnosis of low-risk differentiated thyroid cancer (papillary, follicular, or Hürthle cell carcinoma). Unifocal tumor located in the thyroid isthmus, cT1b No evidence of extrathyroidal extension, assessed by preoperative ultrasound. Exclusion Criteria: \- Aggressive pathological subtypes (e.g., tall cell, clear cell, columnar cell, or diffuse sclerosing variants of papillary thyroid carcinoma, as well as poorly differentiated types). cN1b. M1 Combined with other suspicious thyroid nodules within the lobes.

Primary outcome measure(s)

Rate of 3-year recurrence — maximum of 3 years after the surgery
defined as thyroid cancer recurrence, metastatic disease from thyroid cancer (whichever occurs first)

Trial sites (1)

Facility	City	Region	Status
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07274605 on ClinicalTrials.gov ↗ ← All trials in China