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

NCT07274605 | Not Yet Recruiting DMC

• 1 other identifier: 2025-1245
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

Brief 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

Thymectomy; Thyroid Cancer

Keywords

thyroid cancer; isthmus; surgery

Outcome Measures

Primary Outcomes (1)

• Rate of 3-year recurrence

  defined as thyroid cancer recurrence, metastatic disease from thyroid cancer (whichever occurs first)

  maximum of 3 years after the surgery

Secondary Outcomes (5)

• Anatomical location of tumor recurrence

  maximum of 3 years after the surgery

• Risk of surgical site recurrence

  maximum of 3 years after the surgery

• Health Related Quality of Life

  Baseline (post-randomisation/pre-surgery), 4 weeks and 3, 6,12 months after the surgery

• Number of participants with Hormone Replacement Therapy

  2-4 weeks and 3, 6, 12, 24, 36 months after the surgery

• Rate of surgical complications

  perioperatively, 2-4 weeks, 6 months after the surgery

Study Arms (2)

Total thyroidectomy

ACTIVE COMPARATOR

Patients randomised to this arm will undergo total thyroidectomy with bilateral central compartment (level VI) neck dissection

Procedure: Total thyroidectomy

extended isthmusectomy

EXPERIMENTAL

Patients randomised to this arm will undergo extended isthmusectomy (ensure R0 resection) with bilateral central compartment (level VI) neck dissection

Procedure: Extended isthmusectomy

Interventions

Total thyroidectomy PROCEDURE

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.

Total thyroidectomy

Extended isthmusectomy PROCEDURE

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.

extended isthmusectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.
• Combined with other suspicious thyroid nodules within the lobes.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Zhiyu Li, MD

  Thyroid surgery Department, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingying Zhang, MD

CONTACT

+86 15024439310; jyzhang_hz@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 10, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2032
• Last Updated: December 10, 2025

Record last verified: 2025-10

Locations

CN (1)