Thyroid CancerNCT06738888
Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy
An observational study of Thyroid Cancer and Thyroid Diseases, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
The investigators have previously proposed a prediction model for difficult transoral and submental thyroidectomy through a retrospective study. In order to better promote transoral and submental endoscopic approach for thyroid surgery and to set up an appropriate training course, the investigators aim to refine the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Cancer, Thyroid Diseases, Thyroid Nodule
- What is being tested?
- Modified Strap-Muscle Dissection Technique
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 Dec 2028
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with FNA proven differentiated thyroid cancer, were willing to undergo thyroidectomy and central lymph node dissection via transoral and submental approach. Patients were well informed about the transoral and submental approach and were aware of the potential benefits and risks. Patient consented for us to use perioperative data.
Who may be able to join
- Clinical diagnosis of differentiated thyroid cancer with a maximum diameter not exceeding 4 cm
- Clinical diagnosis of benign thyroid nodule with a maximum diameter not exceeding 6 cm
- Absence of suspicious lateral lymph nodes or distant metastases
Who cannot join
- Participants with fusion or fixation of lymph nodes in the neck
- Participants with history of neck surgery or radiation
- Participants with vocal fold fixation by preoperative fibrolaryngoscope
- Participants with preoperative examination suggestive of extrathyroidal invasion
- Participants with a significantly restricted neck and/or jaw
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, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, 200233
Ling Zhan, Doctor, 08615821120972, 15821120972@163.com
About this study
Official title: A Functional-oriented Modification of TOaST Based on Partial Preservation of the Lines Alba Cervical
The investigators have previously proposed a prediction model for difficult transoral and submental thyroidectomy through a retrospective study. In order to better promote transoral and submental endoscopic approach for thyroid surgery and to set up an appropriate training course, the investigators aim to refine the procedure through a prospective study. As a procedure refinement, a modified strap-muscle dissection technique will be introduced during transoral and submental endoscopic thyroidectomy.
Read the detailed description
This study is a prospectively registered cohort study evaluating postoperative neck functional recovery after TOaST. As a procedure refinement, a modified strap-muscle dissection technique will be introduced during transoral and submental endoscopic thyroidectomy. In the modified approach, the midline separation of the superficial sternohyoid muscle layer will be limited to the upper central neck, approximately to the level of the thyroid cartilage. The deeper sternothyroid muscle layer will be adequately dissected inferiorly as required to maintain sufficient surgical working space. Appropriate lateral retraction of the strap muscles will be used to achieve adequate exposure of the thyroid gland without extending the superficial midline dissection. This refinement is intended to reduce unnecessary disruption of the superficial anterior neck musculature and soft tissues while maintaining satisfactory operative exposure.
Surgical feasibility and safety will be assessed using operative time, intraoperative blood loss, drainage volume, number of central lymph nodes retrieved, recurrent laryngeal nerve events, parathyroid-related outcomes, postoperative complications, and the rate of technical conversion.
- Conditions
- Thyroid Cancer, Thyroid Diseases, Thyroid Nodule
- Being tested
- Modified Strap-Muscle Dissection Technique
- Keywords
- Endoscopic thyroidectomy, Transoral and submental approach, Prediction model
- Medical subject headings
- Thyroid Neoplasms, Thyroid Diseases, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Strap-Muscle Dissection TechniqueProcedure or surgery
A refined endoscopic thyroidectomy technique characterized by limited midline separation of the superficial sternohyoid muscle layer, with preservation of adequate deep-layer sternothyroid dissection and lateral strap-muscle retraction to maintain surgical exposure.
| Study group | Role | What they receive |
|---|---|---|
| Conventional TOaST | In this group, the midline separation of the strap muscles, including the superficial sternohyoid layer, was extended inferiorly toward the suprasternal notch to obtain operative exposure | |
| Modified Strap-Muscle Dissection TOaST | In this group, midline separation of the superficial sternohyoid muscle layer is limited to the upper central neck, approximately to the level of the thyroid cartilage, while adequate dissection of the deeper sternothyroid muscle layer is maintained as required for operative exposure. Lateral retraction of the strap muscles is used to provide sufficient visualization and working space without extending the superficial midline separation to the suprasternal notch. Receives: Procedure: Modified Strap-Muscle Dissection Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative neck functional recovery at 1 month
Postoperative neck functional recovery will be assessed 1 month after surgery using a standardized neck function assessment, including neck discomfort, anterior neck tightness, swallowing-related traction discomfort, and neck range of motion. Higher impairment scores indicate worse neck functional recovery.
Measured: 1 month after surgery
Anterior neck tightness score
Anterior neck tightness will be assessed using a patient-reported visual analog scale or numerical rating scale. Higher scores indicate more severe tightness.
Measured: Postoperative 1 week, 1 month, and 3 months
Swallowing-related traction discomfort
Swallowing-related traction discomfort will be assessed using a patient-reported visual analog scale or numerical rating scale. Higher scores indicate more severe discomfort.
Measured: Postoperative 1 week, 1 month, and 3 months
Secondary outcomes (6)
hospitalization
days of hospitalization
Measured: Length of stay from hospitalisation to discharge
degree of pain
pain intensity was assessed using a standard visual analogue score, with a score of 0 to 10 corresponding to no pain to the most severe pain
Measured: approximately 4 hours after surgery and on postoperative day 1
Number of participants with recurrent laryngeal nerve injury
Impaired vocal cord mobility confirmed by postoperative laryngoscopy
Measured: Through study completion, an average of 1 year
Number of participants with hypoparathyroidism
A postoperative parathyroid hormone level of less than 10 pg/ml
Measured: Through study completion, an average of 1 year
Operative time
Operative time was defined as the duration from incision to closure, and was collected from anesthesia record sheet
Measured: Immediately at the end of the surgery
Central compartment lymph node yield
For participants undergoing central compartment lymph node dissection, the number of retrieved central compartment lymph nodes will be recorded and compared between groups.
Measured: At the time of pathological assessment after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 May 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Zhan, Shanghai 6th People's Hospital
- Investigators
- Ling Zhan, Doctor, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738888
- Sponsor's protocol ID
- 2025-KY-029(K)
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data are available on request due to privacy or other restrictions. The data that support the findings of this study are available on request from Ling Zhan. The data are not publicly available due to them containing information that could compromise research participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Functional-oriented Modification of TOaST Based on Partial Preservation of the Lines Alba Cervical
- ClinicalTrials.gov ID
- NCT06738888
- Acronym / sponsor ID
- 2025-KY-029(K)
- Conditions
- Thyroid Cancer, Thyroid Diseases, Thyroid Nodule
- Keywords
- Endoscopic thyroidectomy, Transoral and submental approach, Prediction model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Dec 2024 (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.
The investigators have previously proposed a prediction model for difficult transoral and submental thyroidectomy through a retrospective study. In order to better promote transoral and submental endoscopic approach for thyroid surgery and to set up an appropriate training course, the investigators aim to refine the procedure through a prospective study. As a procedure refinement, a modified strap-muscle dissection technique will be introduced during transoral and submental endoscopic thyroidectomy.
Detailed description
This study is a prospectively registered cohort study evaluating postoperative neck functional recovery after TOaST. As a procedure refinement, a modified strap-muscle dissection technique will be introduced during transoral and submental endoscopic thyroidectomy. In the modified approach, the midline separation of the superficial sternohyoid muscle layer will be limited to the upper central neck, approximately to the level of the thyroid cartilage. The deeper sternothyroid muscle layer will be adequately dissected inferiorly as required to maintain sufficient surgical working space. Appropriate lateral retraction of the strap muscles will be used to achieve adequate exposure of the thyroid gland without extending the superficial midline dissection. This refinement is intended to reduce unnecessary disruption of the superficial anterior neck musculature and soft tissues while maintaining satisfactory operative exposure.
Surgical feasibility and safety will be assessed using operative time, intraoperative blood loss, drainage volume, number of central lymph nodes retrieved, recurrent laryngeal nerve events, parathyroid-related outcomes, postoperative complications, and the rate of technical conversion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional TOaST | – | –In this group, the midline separation of the strap muscles, including the superficial sternohyoid layer, was extended inferiorly toward the suprasternal notch to obtain operative exposure |
| Modified Strap-Muscle Dissection TOaST | – | Procedure: Modified Strap-Muscle Dissection TechniqueIn this group, midline separation of the superficial sternohyoid muscle layer is limited to the upper central neck, approximately to the level of the thyroid cartilage, while adequate dissection of the deeper sternothyroid muscle layer is maintained as required for operative exposure. Lateral retraction of the strap muscles is used to provide sufficient visualization and working space without extending the superficial midline separation to the suprasternal notch. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with FNA proven differentiated thyroid cancer, were willing to undergo thyroidectomy and central lymph node dissection via transoral and submental approach. Patients were well informed about the transoral and submental approach and were aware of the potential benefits and risks. Patient consented for us to use perioperative data.
Key inclusion criteria (3 listed)
- Clinical diagnosis of differentiated thyroid cancer with a maximum diameter not exceeding 4 cm
- Clinical diagnosis of benign thyroid nodule with a maximum diameter not exceeding 6 cm
- Absence of suspicious lateral lymph nodes or distant metastases
Key exclusion criteria (5 listed)
- Participants with fusion or fixation of lymph nodes in the neck
- Participants with history of neck surgery or radiation
- Participants with vocal fold fixation by preoperative fibrolaryngoscope
- Participants with preoperative examination suggestive of extrathyroidal invasion
- Participants with a significantly restricted neck and/or jaw
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 |
|---|---|---|
| Modified Strap-Muscle Dissection TechniqueA refined endoscopic thyroidectomy technique characterized by limited midline separation of the superficial sternohyoid muscle layer, with preservation of adequate deep-layer sternothyroid dissection and lateral strap-muscle retraction to maintain surgical exposure. | Procedure or surgery | Modified Strap-Muscle Dissection TOaST |
Primary outcome
Postoperative neck functional recovery at 1 month
Time frame: 1 month after surgery
Postoperative neck functional recovery will be assessed 1 month after surgery using a standardized neck function assessment, including neck discomfort, anterior neck tightness, swallowing-related traction discomfort, and neck range of motion. Higher impairment scores indicate worse neck functional recovery.
Anterior neck tightness score
Time frame: Postoperative 1 week, 1 month, and 3 months
Anterior neck tightness will be assessed using a patient-reported visual analog scale or numerical rating scale. Higher scores indicate more severe tightness.
Swallowing-related traction discomfort
Time frame: Postoperative 1 week, 1 month, and 3 months
Swallowing-related traction discomfort will be assessed using a patient-reported visual analog scale or numerical rating scale. Higher scores indicate more severe discomfort.
6 secondary outcomes
hospitalization
Time frame: Length of stay from hospitalisation to discharge
degree of pain
Time frame: approximately 4 hours after surgery and on postoperative day 1
Number of participants with recurrent laryngeal nerve injury
Time frame: Through study completion, an average of 1 year
Number of participants with hypoparathyroidism
Time frame: Through study completion, an average of 1 year
Operative time
Time frame: Immediately at the end of the surgery
Central compartment lymph node yield
Time frame: At the time of pathological assessment after 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 8 Oct 2026.
- Individual participant dataSharing planned: Undecided. Data are available on request due to privacy or other restrictions. The data that support the findings of this study are available on request from Ling Zhan. The data are not publicly available due to them containing information that could compromise research participant privacy.
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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.
Ling Zhan, Doctor principal investigator
Shanghai 6th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer and Thyroid Diseases, run by Shanghai 6th People's Hospital 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. 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 Ling Zhan, Doctor (08615821120972, rebecca0428zhan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative neck functional recovery at 1 month (time frame: 1 month after surgery). The study lists 3 primary outcomes in all. 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 8 Oct 2026.