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

ConditionsThymectomyThyroid Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total thyroidectomy

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

520 Participants
are divided into 2 treatment groups
Group A: Total thyroidectomyActive comparator 1 intervention
Group B: extended isthmusectomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of 3-year recurrence

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

Time frame
maximum of 3 years after the surgery

Secondary outcomes

1

Anatomical location of tumor recurrence

Time frame
maximum of 3 years after the surgery
2

Risk of surgical site recurrence

recurrence occured in the thyroid bed

Time frame
maximum of 3 years after the surgery
3

Health Related Quality of Life

Measured using FoP-Q-SF: Scales range from 12-60 with higher scores indicating greater fear of disease progression Measured using THYCA-Qol questionnaires: including 7 symptom dimensions and 6 single items. All items are rated on a 4-point scale (none, a little, quite a bit, very much), scored from 1 to 4. Higher scores on individual items indicate lower quality of life.

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

Number of participants with Hormone Replacement Therapy

patients who require thyroxin intake

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: