A Clinical Study of Transaxillary Endoscopic and Open Thyroidectomy for PTC

NCT05545852 | Unknown

• 1 other identifier: NFEC-2021-324
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Papillary Thyroid Cancer

Keywords

endoscopic; thyroidectomy

Outcome Measures

Primary Outcomes (6)

• 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.

  30 days after surgery

• 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.

  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.

  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.

  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.

  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.

  1 year after surgery

Secondary Outcomes (7)

• The number of dissected lymph nodes

  3 days after surgery

• The volume of residual gland

  6 month after surgery

• 3-year recurrence rate

  3 years after surgery

• Operation duration

  Intraoperative

• Hospital stays

  3 days after surgery

Study Arms (2)

Study Group

EXPERIMENTAL

Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection

Procedure: GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)

Control Group

ACTIVE COMPARATOR

Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection

Procedure: COT(Conventional Open Thyroidectomy)

Interventions

GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy) PROCEDURE

Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection

Study Group

COT(Conventional Open Thyroidectomy) PROCEDURE

Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient's informed consent;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Links

• Registration on Chinese Clinical Trial Registry

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Shangtong Lei, Dr.

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baihui Sun, Dr.

CONTACT

+8602062787170; sunbh_nfyy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 19, 2022
• Study Start: June 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2025
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

CN (1)