Papillary Thyroid CancerNCT05545852
A Clinical Study of Transaxillary Endoscopic and Open Thyroidectomy for PTC
A study testing GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy) and COT(Conventional Open Thyroidectomy) in people with Papillary Thyroid Cancer, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
To evaluate the feasibility and safety of gasless transaxillary posterior endoscopic thyroidectomy (Resection of thyroid lobe and isthmus, lymph node dissection in the central area of the affected side) and open radical thyroidectomy (Resection of thyroid lobe and isthmus, lymph node dissection in the central area of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Papillary Thyroid Cancer
- What is being tested?
- GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy) and COT(Conventional Open Thyroidectomy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 May 2025
- Phase
- Interventional
- 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
Who may be able to join
- The patient's informed consent;
- 18 years old < age < 70 years old;
- Papillary thyroid carcinoma (Bethesda grade V-VI) was pathologically diagnosed by fine needle aspiration biopsy of the primary thyroid tumor before surgery;
- Color Doppler TI-RADS 4c-5 of primary thyroid tumor;
- The preoperative clinical staging is T1, N0-1a, M0 (see diagnostic criteria for details; according to AJCC-8th TNM tumor staging);
- It is expected that R0 surgical results can be obtained by performing single thyroid lobectomy and isthmus resection + ipsilateral central lymph node dissection;
- Preoperative ASA score I-III.
Who cannot join
- Pregnant or lactating patients;
- Suffering from serious mental illness;
- Preoperative imaging examinations suggest that the tumor is located in the thyroid isthmus or involves bilateral lobes;
- Preoperative imaging examinations suggest the possibility of cervical lateral lymph node or distant metastasis;
- Hashimoto's thyroiditis combined with hyperthyroidism or abnormal thyroid function;
- History of neck surgery;
Show all 15Show fewer
- History of thyroid surgery (including ablation therapy for thyroid nodules);
- Family history of thyroid cancer;
- History of childhood ionizing radiation exposure;
- History of other malignant diseases within 5 years;
- A history of unstable angina or myocardial infarction within 6 months;
- History of cerebral infarction or cerebral hemorrhage within 6 months;
- History of continuous systemic corticosteroid therapy within 1 month;
- Concurrent surgical treatment of other diseases is required;
- Patients who are judged by the investigator to be unsuitable to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Baihui Sun, Dr., +8602062787170, sunbh_nfyy@163.com
Shangtong Lei, Dr.
About this study
Official title: A Multicenter, Randomized, Controlled Clinical Study on the Feasibility and Safety of Gasless Transaxillary Posterior Endoscopic and Open Thyroidectomy for Papillary Thyroid Cancer.
To evaluate the feasibility and safety of gasless transaxillary posterior endoscopic thyroidectomy (Resection of thyroid lobe and isthmus, lymph node dissection in the central area of the affected side) and open radical thyroidectomy (Resection of thyroid lobe and isthmus, lymph node dissection in the central area of the affected side) as the current standard surgical treatment mode in terms of feasibility and safety of radical thyroidectomy.
Read the detailed description
Subjects that suffering from papillary thyroid carcinoma will be randomized into Study Group (gasless transaxillary posterior endoscopic thyroidectomy ) or Control Group (conventional open thyroidectomy). Measure the outcomes as following, early complication rate, life quality score, the number of dissected lymph nodes, the volume of residual gland, 3-year recurrence rate, operation duration, hospital stays, hospitalization expense, and inflammatory and immune response.
- Conditions
- Papillary Thyroid Cancer
- Being tested
- GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy), COT(Conventional Open Thyroidectomy)
- Keywords
- endoscopic, thyroidectomy
- 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.
GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)Procedure or surgery
Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection
COT(Conventional Open Thyroidectomy)Procedure or surgery
Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection Receives: Procedure: GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy) |
| Control Group | Active comparator | Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection Receives: Procedure: COT(Conventional Open Thyroidectomy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early complication rate
Early complications include hemorrhage, surgical site infection, recurrent laryngeal nerve injury, hypoparathyroidism (PTH<15pg/ml, or showing hypocalcification symptoms), chyle leakage, trachea injury, esophageal injury, etc.
Measured: 30 days after surgery
Life quality score (3 days after surgery)
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 3 days after surgery.
Measured: 3 days after surgery
Life quality score (1 month after surgery)
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 1 month after surgery.
Measured: 1 month after surgery
Life quality score (3 months after surgery)
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 3 months after surgery.
Measured: 3 months after surgery
Life quality score (6 months after surgery)
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 6 months after surgery.
Measured: 6 months after surgery
Life quality score (1 year after surgery)
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 1 year after surgery.
Measured: 1 year after surgery
Secondary outcomes (7)
The number of dissected lymph nodes
Record the number of harvest and metastatic lymph nodes.
Measured: 3 days after surgery
The volume of residual gland
Measure the volume of residual gland with ultrasound tests.
Measured: 6 month after surgery
3-year recurrence rate
The rate will be calculated from the day of randomization to the present of evidence of recurrence.
Measured: 3 years after surgery
Operation duration
Record the time from skin discission to incision close.
Measured: Intraoperative
Hospital stays
Record the days from the day of surgery to the day of discharge.
Measured: 3 days after surgery
Hospitalization expense
The total hospitalization expense.
Measured: 3 days after surgery
Inflammatory response
Examine the white blood cell count (WBC), neutrophil count (NEU) and c-reactive protein (CRP) 1 day after surgery.
Measured: 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Jun 2021
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shangtong Lei, Dr., Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545852
- Sponsor's protocol ID
- NFEC-2021-324
- Status last verified
- Oct 2023
- First submitted
- 29 Aug 2022
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Clinical Study on the Feasibility and Safety of Gasless Transaxillary Posterior Endoscopic and Open Thyroidectomy for Papillary Thyroid Cancer.
- ClinicalTrials.gov ID
- NCT05545852
- Acronym / sponsor ID
- NFEC-2021-324
- Conditions
- Papillary Thyroid Cancer
- Keywords
- endoscopic, thyroidectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 19 Sep 2022 (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.
To evaluate the feasibility and safety of gasless transaxillary posterior endoscopic thyroidectomy (Resection of thyroid lobe and isthmus, lymph node dissection in the central area of the affected side) and open radical thyroidectomy (Resection of thyroid lobe and isthmus, lymph node dissection in the central area of the affected side) as the current standard surgical treatment mode in terms of feasibility and safety of radical thyroidectomy.
Detailed description
Subjects that suffering from papillary thyroid carcinoma will be randomized into Study Group (gasless transaxillary posterior endoscopic thyroidectomy ) or Control Group (conventional open thyroidectomy). Measure the outcomes as following, early complication rate, life quality score, the number of dissected lymph nodes, the volume of residual gland, 3-year recurrence rate, operation duration, hospital stays, hospitalization expense, and inflammatory and immune response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection |
| Control Group | Active comparator | Procedure: COT(Conventional Open Thyroidectomy)Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient's informed consent;
- 18 years old < age < 70 years old;
- Papillary thyroid carcinoma (Bethesda grade V-VI) was pathologically diagnosed by fine needle aspiration biopsy of the primary thyroid tumor before surgery;
- Color Doppler TI-RADS 4c-5 of primary thyroid tumor;
- The preoperative clinical staging is T1, N0-1a, M0 (see diagnostic criteria for details; according to AJCC-8th TNM tumor staging);
Key exclusion criteria (15 listed)
- Pregnant or lactating patients;
- Suffering from serious mental illness;
- Preoperative imaging examinations suggest that the tumor is located in the thyroid isthmus or involves bilateral lobes;
- Preoperative imaging examinations suggest the possibility of cervical lateral lymph node or distant metastasis;
- Hashimoto's thyroiditis combined with hyperthyroidism or abnormal thyroid function;
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 |
|---|---|---|
| GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection | Procedure or surgery | Study Group |
| COT(Conventional Open Thyroidectomy)Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection | Procedure or surgery | Control Group |
Primary outcome
Early complication rate
Time frame: 30 days after surgery
Early complications include hemorrhage, surgical site infection, recurrent laryngeal nerve injury, hypoparathyroidism (PTH<15pg/ml, or showing hypocalcification symptoms), chyle leakage, trachea injury, esophageal injury, etc.
Life quality score (3 days after surgery)
Time frame: 3 days after surgery
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 3 days after surgery.
Life quality score (1 month after surgery)
Time frame: 1 month after surgery
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 1 month after surgery.
Life quality score (3 months after surgery)
Time frame: 3 months after surgery
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 3 months after surgery.
Life quality score (6 months after surgery)
Time frame: 6 months after surgery
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 6 months after surgery.
Life quality score (1 year after surgery)
Time frame: 1 year after surgery
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 1 year after surgery.
7 secondary outcomes
The number of dissected lymph nodes
Time frame: 3 days after surgery
The volume of residual gland
Time frame: 6 month after surgery
3-year recurrence rate
Time frame: 3 years after surgery
Operation duration
Time frame: Intraoperative
Hospital stays
Time frame: 3 days after surgery
Hospitalization expense
Time frame: 3 days after surgery
Inflammatory response
Time frame: 1 day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Registration on Chinese Clinical Trial RegistryLink provided by the sponsor.
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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.
Shangtong Lei, Dr. principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy) and COT(Conventional Open Thyroidectomy) in people with Papillary Thyroid Cancer, run by Nanfang Hospital, Southern Medical 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 7 inclusion and 15 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 18 Oct 2023. 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 Baihui Sun, Dr. (+8602062787170, sunbh_nfyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early complication rate (time frame: 30 days after surgery). The study lists 6 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 18 Oct 2023.