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A Clinical Study of Transaxillary Endoscopic and Open Thyroidectomy for PTC

Primary Purpose

Papillary Thyroid Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)
COT(Conventional Open Thyroidectomy)
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papillary Thyroid Cancer focused on measuring endoscopic, thyroidectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanfang Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group

Control Group

Arm Description

Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection

Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

The number of dissected lymph nodes
Record the number of harvest and metastatic lymph nodes.
The volume of residual gland
Measure the volume of residual gland with ultrasound tests.
3-year recurrence rate
The rate will be calculated from the day of randomization to the present of evidence of recurrence.
Operation duration
Record the time from skin discission to incision close.
Hospital stays
Record the days from the day of surgery to the day of discharge.
Hospitalization expense
The total hospitalization expense.
Inflammatory response
Examine the white blood cell count (WBC), neutrophil count (NEU) and c-reactive protein (CRP) 1 day after surgery.

Full Information

First Posted
August 29, 2022
Last Updated
October 16, 2023
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05545852
Brief Title
A Clinical Study of Transaxillary Endoscopic and Open Thyroidectomy for PTC
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Thyroid Cancer
Keywords
endoscopic, thyroidectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection
Intervention Type
Procedure
Intervention Name(s)
GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)
Intervention Description
Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection
Intervention Type
Procedure
Intervention Name(s)
COT(Conventional Open Thyroidectomy)
Intervention Description
Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection
Primary Outcome Measure Information:
Title
Early complication rate
Description
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.
Time Frame
30 days after surgery
Title
Life quality score (3 days after surgery)
Description
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 3 days after surgery.
Time Frame
3 days after surgery
Title
Life quality score (1 month after surgery)
Description
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 1 month after surgery.
Time Frame
1 month after surgery
Title
Life quality score (3 months after surgery)
Description
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 3 months after surgery.
Time Frame
3 months after surgery
Title
Life quality score (6 months after surgery)
Description
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 6 months after surgery.
Time Frame
6 months after surgery
Title
Life quality score (1 year after surgery)
Description
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 1 year after surgery.
Time Frame
1 year after surgery
Secondary Outcome Measure Information:
Title
The number of dissected lymph nodes
Description
Record the number of harvest and metastatic lymph nodes.
Time Frame
3 days after surgery
Title
The volume of residual gland
Description
Measure the volume of residual gland with ultrasound tests.
Time Frame
6 month after surgery
Title
3-year recurrence rate
Description
The rate will be calculated from the day of randomization to the present of evidence of recurrence.
Time Frame
3 years after surgery
Title
Operation duration
Description
Record the time from skin discission to incision close.
Time Frame
Intraoperative
Title
Hospital stays
Description
Record the days from the day of surgery to the day of discharge.
Time Frame
3 days after surgery
Title
Hospitalization expense
Description
The total hospitalization expense.
Time Frame
3 days after surgery
Title
Inflammatory response
Description
Examine the white blood cell count (WBC), neutrophil count (NEU) and c-reactive protein (CRP) 1 day after surgery.
Time Frame
1 day after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baihui Sun, Dr.
Phone
+8602062787170
Email
sunbh_nfyy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shangtong Lei, Dr.
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baihui Sun, Dr.
Phone
+8602062787170
Email
sunbh_nfyy@163.com
First Name & Middle Initial & Last Name & Degree
Shangtong Lei, Dr.
First Name & Middle Initial & Last Name & Degree
Tao Wei, Dr.
First Name & Middle Initial & Last Name & Degree
Chuanming Zheng, Dr.
First Name & Middle Initial & Last Name & Degree
Xin Lin, Dr.

12. IPD Sharing Statement

Links:
URL
http://www.chictr.org.cn/showproj.aspx?proj=51290
Description
Registration on Chinese Clinical Trial Registry

Learn more about this trial

A Clinical Study of Transaxillary Endoscopic and Open Thyroidectomy for PTC

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