Comparison of the Effects of Needle Biopsy Tract Resection and Non-resection on Recurrence Rate in Patients With Primary Extremity Sarcoma

This randomized, non-inferiority clinical trial aims to evaluate whether non-resection of needle biopsy tract is non-inferior to routine biopsy tract resection in terms of local recurrence in patients with primary extremity musculoskeletal sarcoma undergoing en-bloc surgical treatment. Biopsy tract resection is traditionally recommended to reduce the risk of tumor seeding; however, its benefit in reducing recurrence has not been definitively demonstrated, particularly when core needle biopsy is widely used. Also, avoiding biopsy tract resection may preserve uninvolved tissue without compromising oncologic safety. The primary objective of this study is to compare local recurrence rates between patients who undergo biopsy tract resection and those who do not. Secondary objectives include comparisons of surgical complications, functional outcomes, overall survival, and progression-free survival.

NCT Number	NCT07575724
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions	Primary, Sarcoma
Enrollment	3,300 participants
Start Date	2026-12-01
Primary Completion	2031-12-01 (estimated)
Study Completion	2033-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-14