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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

290

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Nanfang Hospital, Southern Medical University

Investigators

  • 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)

June 1, 2021

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (Actual)

September 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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