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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Papillary Thyroid Cancer Procedure: GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy) Procedure: COT(Conventional Open Thyroidectomy) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2025

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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.

  5. 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. 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.


Secondary Outcome Measures :
  1. The number of dissected lymph nodes [ Time Frame: 3 days after surgery ]
    Record the number of harvest and metastatic lymph nodes.

  2. The volume of residual gland [ Time Frame: 6 month after surgery ]
    Measure the volume of residual gland with ultrasound tests.

  3. 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.

  4. Operation duration [ Time Frame: Intraoperative ]
    Record the time from skin discission to incision close.

  5. Hospital stays [ Time Frame: 3 days after surgery ]
    Record the days from the day of surgery to the day of discharge.

  6. Hospitalization expense [ Time Frame: 3 days after surgery ]
    The total hospitalization expense.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05545852


Contacts
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Contact: Baihui Sun, Dr. +8602062787170 sunbh_nfyy@163.com

Locations
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China, Guangdong
Nanfang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Baihui Sun, Dr.    +8602062787170    sunbh_nfyy@163.com   
Principal Investigator: Shangtong Lei, Dr.         
Sub-Investigator: Tao Wei, Dr.         
Sub-Investigator: Chuanming Zheng, Dr.         
Sub-Investigator: Xin Lin, Dr.         
Sponsors and Collaborators
Nanfang Hospital, Southern Medical University
Investigators
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Principal Investigator: Shangtong Lei, Dr. Nanfang Hospital, Southern Medical University
More Information
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Additional Information:

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Responsible Party: Nanfang Hospital, Southern Medical University
ClinicalTrials.gov Identifier: NCT05545852    
Other Study ID Numbers: NFEC-2021-324
First Posted: September 19, 2022    Key Record Dates
Last Update Posted: October 18, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanfang Hospital, Southern Medical University:
endoscopic
thyroidectomy
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Adenocarcinoma, Papillary
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type