Differentiated Thyroid CancerNCT06671184
Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy
An observational study of Differentiated Thyroid Cancer, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
No prior studies have stratified the difficulty of transoral and submental thyroidectomy (TOaST). The investigators aimed to investigate preoperative factors as indicators of difficult TOaSTs and to develop a predictive model accordingly. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Differentiated Thyroid Cancer
- What is being tested?
- Observations on clinicopathological factors influencing the difficulty of surgery
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2027
- 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 total 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
- Absence of suspicious lateral lymph nodes or distant metastases
- Participants with high cosmetic expectations
- Participants who underwent total thyroidectomy and central lymph node dissection.
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
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, Shanghai Municipality, 200233
Ling Zhan, Doctor, 08615821120972, rebecca0428zhan@163.com
About this study
No prior studies have stratified the difficulty of transoral and submental thyroidectomy (TOaST). The investigators aimed to investigate preoperative factors as indicators of difficult TOaSTs and to develop a predictive model accordingly.
Read the detailed description
Thyroid cancer is the most common endocrine malignancy, with a female predominance. Thyroidectomy is the main treatment for thyroid cancer, and considering the good prognosis of thyroid cancer, endoscopic thyroid surgery, which avoids neck incision, is being widely used in the clinic in order to improve the life treatment of patients. Among them, endoscopic thyroidectomy with transoral approach has a shorter learning curve because of the short surgical path. However, due to the complex structure of the neck, small space, and rich blood supply of the thyroid gland, surrounded by parathyroid glands and important nerves, endoscopic thyroid is difficult and has a long learning curve. In addition, a series of complications such as haemorrhage, hypoparathyroidism and laryngeal reentrant nerve injury can seriously affect the quality of patient survival. Difficult thyroidectomy is usually characterized by a long operative time, high intraoperative bleeding and a high incidence of postoperative complications. According to the literature, in open thyroid surgery, the degree of difficulty is associated with factors such as goiter, inflammation, and hyperthyroidism. However, the degree of difficulty of thyroidectomy due to various factors varies and is difficult to predict. Surgical difficulty is closely related to the outcome and safety of thyroidectomy, which is an urgent concern for surgeons. And there is no study on the degree of difficulty of transoral and submental endoscopic thyroidectomy, therefore, there is an urgent need for an effective and objective method to determine the preoperative factors affecting the degree of surgical difficulty and to establish a model for validation, so that it can be subsequently replicated in other hospitals.
- Conditions
- Differentiated Thyroid Cancer
- Being tested
- Observations on clinicopathological factors influencing the difficulty of surgery
- Keywords
- Differentiated thyroid cancer, Transoral and submental thyroidectomy, Surgical difficulty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observations on clinicopathological factors influencing the difficulty of surgeryOther
Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data
| Study group | Role | What they receive |
|---|---|---|
| Difficult transoral and submental thyroidectomy | (1) operative time more than 75% of the overall study cases (2) severe intraoperative vascular or recurrent laryngeal nerve injury Receives: Other: Observations on clinicopathological factors influencing the difficulty of surgery | |
| Normal transoral and submental thyroidectomy | the remaining of the entire study cases excluding the difficult cases Receives: Other: Observations on clinicopathological factors influencing the difficulty of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Number of participants with mental nerve injury
a postoperative numbness in the lower lip and submental area
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: through study completion, an average of 1 year
Secondary outcomes (2)
hospitalization
days of hospitalization
Measured: through study completion, an average of 1 year
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Jan 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Differentiated 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
- 500 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
- NCT06671184
- Sponsor's protocol ID
- 2024-KY-236(K)
- Status last verified
- May 2026
- First submitted
- 30 Oct 2024
- Last updated
- 7 May 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.
Publications
Zhan L, Xuan M, Ding H, Liang J, Zhao Q, Chen L, Yang Z, Cheng X, Kuang J, Yan J, Cai W, Qiu W. Learning curve of trans-areola single-site endoscopic thyroidectomy in a high-volume center: A CUSUM-based assessment. Cancer Med. 2023 Aug;12(16):16846-16858. doi: 10.1002/cam4.6307. Epub 2023 Jul 3.
PubMed 37395126Liang J, Zhan L, Xuan M, Zhao Q, Chen L, Yan J, Kuang J, Tan J, Qiu W. Thyroidectomy for thyroid cancer via transareola single-site endoscopic approach: results of a case-match study with large-scale population. Surg Endosc. 2022 Feb;36(2):1394-1406. doi: 10.1007/s00464-021-08424-y. Epub 2021 Mar 29.
PubMed 33782758
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy
- ClinicalTrials.gov ID
- NCT06671184
- Acronym / sponsor ID
- 2024-KY-236(K)
- Conditions
- Differentiated Thyroid Cancer
- Keywords
- Differentiated thyroid cancer, Transoral and submental thyroidectomy, Surgical difficulty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Nov 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.
No prior studies have stratified the difficulty of transoral and submental thyroidectomy (TOaST). The investigators aimed to investigate preoperative factors as indicators of difficult TOaSTs and to develop a predictive model accordingly.
Detailed description
Thyroid cancer is the most common endocrine malignancy, with a female predominance. Thyroidectomy is the main treatment for thyroid cancer, and considering the good prognosis of thyroid cancer, endoscopic thyroid surgery, which avoids neck incision, is being widely used in the clinic in order to improve the life treatment of patients. Among them, endoscopic thyroidectomy with transoral approach has a shorter learning curve because of the short surgical path. However, due to the complex structure of the neck, small space, and rich blood supply of the thyroid gland, surrounded by parathyroid glands and important nerves, endoscopic thyroid is difficult and has a long learning curve. In addition, a series of complications such as haemorrhage, hypoparathyroidism and laryngeal reentrant nerve injury can seriously affect the quality of patient survival. Difficult thyroidectomy is usually characterized by a long operative time, high intraoperative bleeding and a high incidence of postoperative complications. According to the literature, in open thyroid surgery, the degree of difficulty is associated with factors such as goiter, inflammation, and hyperthyroidism. However, the degree of difficulty of thyroidectomy due to various factors varies and is difficult to predict. Surgical difficulty is closely related to the outcome and safety of thyroidectomy, which is an urgent concern for surgeons. And there is no study on the degree of difficulty of transoral and submental endoscopic thyroidectomy, therefore, there is an urgent need for an effective and objective method to determine the preoperative factors affecting the degree of surgical difficulty and to establish a model for validation, so that it can be subsequently replicated in other hospitals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Difficult transoral and submental thyroidectomy | – | Other: Observations on clinicopathological factors influencing the difficulty of surgery(1) operative time more than 75% of the overall study cases (2) severe intraoperative vascular or recurrent laryngeal nerve injury |
| Normal transoral and submental thyroidectomy | – | Other: Observations on clinicopathological factors influencing the difficulty of surgerythe remaining of the entire study cases excluding the difficult cases |
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 total 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 (4 listed)
- Clinical diagnosis of differentiated thyroid cancer with a maximum diameter not exceeding 4 cm
- Absence of suspicious lateral lymph nodes or distant metastases
- Participants with high cosmetic expectations
- Participants who underwent total thyroidectomy and central lymph node dissection.
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
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 |
|---|---|---|
| Observations on clinicopathological factors influencing the difficulty of surgeryAge, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data | Other | Difficult transoral and submental thyroidectomy, Normal transoral and submental thyroidectomy |
Primary outcome
Number of participants with recurrent laryngeal nerve injury
Time frame: through study completion, an average of 1 year
impaired vocal cord mobility confirmed by postoperative laryngoscopy
Number of participants with hypoparathyroidism
Time frame: through study completion, an average of 1 year
a postoperative parathyroid hormone level of less than 10 pg/ml
Number of participants with mental nerve injury
Time frame: through study completion, an average of 1 year
a postoperative numbness in the lower lip and submental area
operative time
Time frame: through study completion, an average of 1 year
operative time was defined as the duration from incision to closure, and was collected from anesthesia record sheet
2 secondary outcomes
hospitalization
Time frame: through study completion, an average of 1 year
degree of pain
Time frame: approximately 4 hours after surgery and on postoperative day 1
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 7 May 2026.
- Results publication: PubMed 37395126Zhan L, Xuan M, Ding H, Liang J, Zhao Q, Chen L, Yang Z, Cheng X, Kuang J, Yan J, Cai W, Qiu W. Learning curve of trans-areola single-site endoscopic thyroidectomy in a high-volume center: A CUSUM-based assessment. Cancer Med. 2023 Aug;12(16):16846-16858. doi: 10.1002/cam4.6307. Epub 2023 Jul 3.
- Results publication: PubMed 33782758Liang J, Zhan L, Xuan M, Zhao Q, Chen L, Yan J, Kuang J, Tan J, Qiu W. Thyroidectomy for thyroid cancer via transareola single-site endoscopic approach: results of a case-match study with large-scale population. Surg Endosc. 2022 Feb;36(2):1394-1406. doi: 10.1007/s00464-021-08424-y. Epub 2021 Mar 29.
- 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 Differentiated Thyroid Cancer, 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 4 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 7 May 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?
Number of participants with recurrent laryngeal nerve injury (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06671184, which also lists 2 linked publications.
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 7 May 2026.