Papillary Thyroid CarcinomaNCT06592755
Single-Incision Gasless Endoscopic Total Thyroidectomy Via Subclavian Approach Versus Open Surgery for PTC
An observational study of Papillary Thyroid Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Historically, performing a contralateral thyroid lobectomy and lymph node dissection via the subclavian approach was considered challenging. This study aimed to evaluate the safety and feasibility of single-incision gasless endoscopic total thyroidectomy and central compartment neck dissection via the subclavian… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Papillary Thyroid Carcinoma
- What is being tested?
- single-incision, gasless endoscopic total thyroidectomy with central compartment neck dissection and conventional open surgery
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2024to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients, who were diagnosed with papillary thyroid carcinoma at our center, chose to undergo either single-incision, gasless endoscopic total thyroidectomy with central compartment neck dissection via the subclavian approach or conventional open surgery.
Who may be able to join
- (1) thyroid neoplasm \<3.0 cm;
- (2) well differentiated papillary thyroid carcinoma.
Who cannot join
- (1) extrathyroidal extensions estimated in ultrasonography scan;
- (2) enlarged lymph nodes in lateral neck compartment on palpation, or US scan;
- (3) suspected distant metastases;
- (4) previous history of neck radiation therapy and/or surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120
Lin, 0086-020-34071439, linpliang3@mail.sysu.edu.cn
About this study
Official title: Single-Incision Gasless Endoscopic Total Thyroidectomy Via Subclavian Approach Versus Open Surgery for Papillary Thyroid Carcinoma
Historically, performing a contralateral thyroid lobectomy and lymph node dissection via the subclavian approach was considered challenging. This study aimed to evaluate the safety and feasibility of single-incision gasless endoscopic total thyroidectomy and central compartment neck dissection via the subclavian approach (SCA) in comparison to conventional open surgery for the treatment of papillary thyroid carcinoma (PTC) retrospectively.
Read the detailed description
Historically, performing a contralateral thyroid lobectomy and lymph node dissection via the subclavian approach was considered challenging. This study aimed to evaluate the safety and feasibility of single-incision gasless endoscopic total thyroidectomy and central compartment neck dissection via the subclavian approach (SCA) in comparison to conventional open surgery for the treatment of papillary thyroid carcinoma (PTC) retrospectively.
- Conditions
- Papillary Thyroid Carcinoma
- Being tested
- single-incision, gasless endoscopic total thyroidectomy with central compartment neck dissection, conventional open surgery
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-incision, gasless endoscopic total thyroidectomy with central compartment neck dissectionProcedure or surgery
The included patients chose to undergo single-incision, gasless endoscopic total thyroidectomy with central compartment neck dissection via the subclavian approach based on patients preference.
conventional open surgeryProcedure or surgery
These patients chose to undergo total thyroidectomy with central compartment neck dissection via conventional open surgery based on patients preference.
| Study group | Role | What they receive |
|---|---|---|
| the Subclavian Approach group | The patients chose to undergo total thyroidectomy and central compartment neck dissection via the single-incision subclavian approach. Receives: Procedure: single-incision, gasless endoscopic total thyroidectomy with central compartment neck dissection | |
| the conventional open surgery group | The patients chose to undergo total thyroidectomy and central compartment neck dissection via the conventional open surgery approach. Receives: Procedure: conventional open surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
the disease-free survival
The disease-free survival refers to the probability of survival without any biologic, structural, or functional events.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Sep 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592755
- Sponsor's protocol ID
- SYSKY-2023-1124-01
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Incision Gasless Endoscopic Total Thyroidectomy Via Subclavian Approach Versus Open Surgery for Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT06592755
- Acronym / sponsor ID
- SYSKY-2023-1124-01
- Conditions
- Papillary Thyroid Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 19 Sep 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.
Historically, performing a contralateral thyroid lobectomy and lymph node dissection via the subclavian approach was considered challenging. This study aimed to evaluate the safety and feasibility of single-incision gasless endoscopic total thyroidectomy and central compartment neck dissection via the subclavian approach (SCA) in comparison to conventional open surgery for the treatment of papillary thyroid carcinoma (PTC) retrospectively.
Detailed description
Historically, performing a contralateral thyroid lobectomy and lymph node dissection via the subclavian approach was considered challenging. This study aimed to evaluate the safety and feasibility of single-incision gasless endoscopic total thyroidectomy and central compartment neck dissection via the subclavian approach (SCA) in comparison to conventional open surgery for the treatment of papillary thyroid carcinoma (PTC) retrospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the Subclavian Approach group | – | Procedure: single-incision, gasless endoscopic total thyroidectomy with central compartment neck dissectionThe patients chose to undergo total thyroidectomy and central compartment neck dissection via the single-incision subclavian approach. |
| the conventional open surgery group | – | Procedure: conventional open surgeryThe patients chose to undergo total thyroidectomy and central compartment neck dissection via the conventional open surgery approach. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients, who were diagnosed with papillary thyroid carcinoma at our center, chose to undergo either single-incision, gasless endoscopic total thyroidectomy with central compartment neck dissection via the subclavian approach or conventional open surgery.
Key inclusion criteria (2 listed)
- (1) thyroid neoplasm \<3.0 cm;
- (2) well differentiated papillary thyroid carcinoma.
Key exclusion criteria (4 listed)
- (1) extrathyroidal extensions estimated in ultrasonography scan;
- (2) enlarged lymph nodes in lateral neck compartment on palpation, or US scan;
- (3) suspected distant metastases;
- (4) previous history of neck radiation therapy and/or surgery.
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 |
|---|---|---|
| single-incision, gasless endoscopic total thyroidectomy with central compartment neck dissectionThe included patients chose to undergo single-incision, gasless endoscopic total thyroidectomy with central compartment neck dissection via the subclavian approach based on patients preference. | Procedure or surgery | the Subclavian Approach group |
| conventional open surgeryThese patients chose to undergo total thyroidectomy with central compartment neck dissection via conventional open surgery based on patients preference. | Procedure or surgery | the conventional open surgery group |
Primary outcome
the disease-free survival
Time frame: up to 24 months
The disease-free survival refers to the probability of survival without any biologic, structural, or functional events.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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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. This study is not recruiting at the moment.
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 Papillary Thyroid Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 2 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin (0086-020-34071439, linpliang3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the disease-free survival (time frame: up to 24 months). 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 1 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.