A Clinical Study of Transaxillary Endoscopic and Open Thyroidectomy for PTC

October 16, 2023 updated by: Nanfang Hospital, Southern Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:
        • Principal Investigator:
          • Shangtong Lei, Dr.
        • Sub-Investigator:
          • Tao Wei, Dr.
        • Sub-Investigator:
          • Chuanming Zheng, Dr.
        • Sub-Investigator:
          • Xin Lin, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study Group
Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection
Procedure: GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)
Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection
Active Comparator: Control Group
Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection
Procedure: COT(Conventional Open Thyroidectomy)
Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 days after surgery
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.
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.
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.
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.
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.
1 year after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of dissected lymph nodes
Time Frame: 3 days after surgery
Record the number of harvest and metastatic lymph nodes.
3 days after surgery
The volume of residual gland
Time Frame: 6 month after surgery
Measure the volume of residual gland with ultrasound tests.
6 month after surgery
3-year recurrence rate
Time Frame: 3 years after surgery
The rate will be calculated from the day of randomization to the present of evidence of recurrence.
3 years after surgery
Operation duration
Time Frame: Intraoperative
Record the time from skin discission to incision close.
Intraoperative
Hospital stays
Time Frame: 3 days after surgery
Record the days from the day of surgery to the day of discharge.
3 days after surgery
Hospitalization expense
Time Frame: 3 days after surgery
The total hospitalization expense.
3 days after surgery
Inflammatory response
Time Frame: 1 day after surgery
Examine the white blood cell count (WBC), neutrophil count (NEU) and c-reactive protein (CRP) 1 day after surgery.
1 day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital, Southern Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shangtong Lei, Dr., Nanfang Hospital, Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NFEC-2021-324

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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