ThymectomyNCT07274605
Comparing the Therapeutic Efficacy of Extended Isthmusectomy Versus Total Thyroidectomy for Isthmus Tumors of the Thyroid
A study testing Total thyroidectomy and Extended isthmusectomy in people with Thymectomy and Thyroid Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thymectomy, Thyroid Cancer
- What is being tested?
- Total thyroidectomy and Extended isthmusectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2025to 1 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310000
About this study
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.
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).
Read the 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.
- Conditions
- Thymectomy, Thyroid Cancer
- Being tested
- Total thyroidectomy, Extended isthmusectomy
- Keywords
- thyroid cancer, isthmus, surgery
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total thyroidectomyProcedure or 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 isthmusectomyProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Total thyroidectomy | Active comparator | Patients randomised to this arm will undergo total thyroidectomy with bilateral central compartment (level VI) neck dissection Receives: 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 Receives: Procedure: Extended isthmusectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of 3-year recurrence
defined as thyroid cancer recurrence, metastatic disease from thyroid cancer (whichever occurs first)
Measured: maximum of 3 years after the surgery
Secondary outcomes (5)
Anatomical location of tumor recurrence
Measured: maximum of 3 years after the surgery
Risk of surgical site recurrence
recurrence occured in the thyroid bed
Measured: maximum of 3 years after the surgery
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.
Measured: Baseline (post-randomisation/pre-surgery), 4 weeks and 3, 6,12 months after the surgery
Number of participants with Hormone Replacement Therapy
patients who require thyroxin intake
Measured: 2-4 weeks and 3, 6, 12, 24, 36 months after the surgery
Rate of surgical complications
including transient/permanent hypoparathyroidism, transient/permanent recurrent laryngeal nerve injury, postoperative infection, and postoperative lymphatic fistula.
Measured: perioperatively, 2-4 weeks, 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start19 Dec 2025 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThymectomyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhiyu Li, MD, Principal investigator, Thyroid surgery Department, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274605
- Sponsor's protocol ID
- 2025-1245
- Status last verified
- Oct 2025
- First submitted
- 24 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07274605
- Acronym / sponsor ID
- 2025-1245
- Conditions
- Thymectomy, Thyroid Cancer
- Keywords
- thyroid cancer, isthmus, surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 19 Dec 2025 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total thyroidectomy | Active comparator | Procedure: Total thyroidectomyPatients randomised to this arm will undergo total thyroidectomy with bilateral central compartment (level VI) neck dissection |
| extended isthmusectomy | Experimental | Procedure: Extended isthmusectomyPatients randomised to this arm will undergo extended isthmusectomy (ensure R0 resection) with bilateral central compartment (level VI) neck dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total thyroidectomyTotal 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 or surgery | Total thyroidectomy |
| Extended isthmusectomyExtended 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. | Procedure or surgery | extended isthmusectomy |
Primary outcome
Rate of 3-year recurrence
Time frame: maximum of 3 years after the surgery
defined as thyroid cancer recurrence, metastatic disease from thyroid cancer (whichever occurs first)
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhiyu Li, MD principal investigator
Thyroid surgery Department, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total thyroidectomy and Extended isthmusectomy in people with Thymectomy and Thyroid Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingying Zhang, MD (+86 15024439310, jyzhang_hz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of 3-year recurrence (time frame: maximum of 3 years after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.