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NOT YET RECRUITING
NCT07654322

Clinical Study on the Efficacy of Laparoscopic Assisted Open Surgery Through Subclavian Approach for Unilateral Thyroid Cancer

Sponsor: Xijing Hospital

View on ClinicalTrials.gov

Summary

This study compares the clinical efficacy of non inflatable subclavian endoscopic surgery and open surgery for unilateral thyroid cancer, aiming to compare the differences in lymph node dissection rate, complication rate, surgical time, hospitalization time, drainage tube placement time and other indicators between the two surgical procedures, and provide guidance for surgical selection and safety in the later stage. This study is a clinical controlled trial that plans to include 400 consecutive patients with thyroid cancer. After being fully informed and signing the informed consent form, the subjects will enter the trial period after being screened and qualified. The subjects will undergo non inflatable subclavian endoscopic thyroidectomy or open subclavian thyroidectomy according to their own wishes. The enrollment period is from March 2026-2028. The follow-up period should be at least 5 years. After the start of the experiment, a recruitment notice and corresponding recruitment manual will be issued, with a planned recruitment of 100 patients. The preparation stage for clinical research should include the preparation, distribution, and confirmation of research documents, as well as personnel training; Sign the informed consent form and screen the subjects. The surgical method for thyroid cancer is determined by the surgeon based on the patient's condition and after communication with the patient Evaluate the number of lymph nodes and metastatic lymph nodes in the central area by the pathology department, organize the operation time according to the surgical records, calculate the patient's drainage volume and hospitalization time according to the nursing records, and conduct telephone follow-up on patient satisfaction in the later stage. Establish individual patient information using the existing thyroid cancer database in the department, recording general information, diagnosis and treatment history, and other relevant data.

Official title: Multicenter Prospective Cohort Clinical Study on the Efficacy of Pneumoperitoneum-Free, Subclavian Transaxillary Laparoscopic-Assisted Versus Open Surgery for Unilateral Thyroid Cancer

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2026-07-01

Completion Date

2031-02-28

Last Updated

2026-06-17

Healthy Volunteers

No

Conditions