Comparing the Therapeutic Efficacy of Extended Isthmusectomy Versus Total Thyroidectomy for Isthmus Tumors of the Thyroid
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total thyroidectomy, Extended isthmusectomy.
- Who it may be relevant to
- Registry conditions: Thymectomy, Thyroid Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparing the Therapeutic Efficacy of Extended Isthmusectomy Versus Total Thyroidectomy for Isthmus Tumors of the Thyroid: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial.
Overview
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).
Detailed description
The thyroid isthmus is a narrow structure connecting the two lobes of the thyroid. Papillary carcinoma arising from this site accounts for only 1-9% of all thyroid cancers. However, due to its unique anatomical location, it is more prone to extranodal extension and bilateral lymph node metastasis, exhibiting more aggressive biological behavior. The optimal extent of surgery remains controversial: total thyroidectomy facilitates postoperative radioactive iodine therapy and monitoring but results in permanent dependence on thyroid hormone replacement and increases the risk of complications such as hypocalcemia, adversely affecting patients' quality of life. In contrast, conservative approaches like extended isthmusectomy can preserve partial thyroid function, reduce complications, and maintain a better quality of life, making them particularly suitable for low-risk patients with small tumors and no metastasis. Existing retrospective studies indicate no significant difference in recurrence rates between the two surgical approaches, though the evidence remains limited. Therefore, this study aims to conduct a prospective, multicenter, open-label, parallel-controlled, randomized trial to directly compare total thyroidectomy and extended isthmusectomy in terms of postoperative recurrence rates, quality of life, and complications, thereby providing high-quality evidence for surgical decision-making.
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, w - 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.
Primary outcome measures
- Rate of 3-year recurrence [Time frame: maximum of 3 years after the surgery]
Secondary outcome measures (5)
- Anatomical location of tumor recurrence [Time frame: maximum of 3 years after the surgery]
- Risk of surgical site recurrence [Time frame: maximum of 3 years after the surgery]
- Health Related Quality of Life [Time frame: Baseline (post-randomisation/pre-surgery), 4 weeks and 3, 6,12 months after the surgery]
- Number of participants with Hormone Replacement Therapy [Time frame: 2-4 weeks and 3, 6, 12, 24, 36 months after the surgery]
- Rate of surgical complications [Time frame: perioperatively, 2-4 weeks, 6 months after the surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou
Identifiers
NCT: NCT07274605 · 2025-1245