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A Clinical Study of Transaxillary Endoscopic and Open Thyroidectomy for PTC

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ClinicalTrials.gov Identifier: NCT05545852
Recruitment Status : Recruiting
First Posted : September 19, 2022
Last Update Posted : October 18, 2023
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital, Southern Medical University

Tracking Information
First Submitted Date  ICMJE August 29, 2022
First Posted Date  ICMJE September 19, 2022
Last Update Posted Date October 18, 2023
Actual Study Start Date  ICMJE June 1, 2021
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2022)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2022)
  • The number of dissected lymph nodes [ Time Frame: 3 days after surgery ]
    Record the number of harvest and metastatic lymph nodes.
  • The volume of residual gland [ Time Frame: 6 month after surgery ]
    Measure the volume of residual gland with ultrasound tests.
  • 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.
  • Operation duration [ Time Frame: Intraoperative ]
    Record the time from skin discission to incision close.
  • Hospital stays [ Time Frame: 3 days after surgery ]
    Record the days from the day of surgery to the day of discharge.
  • Hospitalization expense [ Time Frame: 3 days after surgery ]
    The total hospitalization expense.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study of Transaxillary Endoscopic and Open Thyroidectomy for PTC
Official Title  ICMJE A Multicenter, Randomized, Controlled Clinical Study on the Feasibility and Safety of Gasless Transaxillary Posterior Endoscopic and Open Thyroidectomy for Papillary Thyroid Cancer.
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Papillary Thyroid Cancer
Intervention  ICMJE
  • Procedure: GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)
    Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection
  • Procedure: COT(Conventional Open Thyroidectomy)
    Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection
Study Arms  ICMJE
  • Experimental: Study Group
    Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection
    Intervention: Procedure: GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)
  • Active Comparator: Control Group
    Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection
    Intervention: Procedure: COT(Conventional Open Thyroidectomy)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 15, 2022)		 290
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2025
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Baihui Sun, Dr. +8602062787170 sunbh_nfyy@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05545852
Other Study ID Numbers  ICMJE NFEC-2021-324
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Nanfang Hospital, Southern Medical University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Nanfang Hospital, Southern Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shangtong Lei, Dr. Nanfang Hospital, Southern Medical University
PRS Account Nanfang Hospital, Southern Medical University
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP