The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction

This study is a multicenter, open-label, randomized controlled trial. It will prospectively compare outcomes between patients undergoing reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) with the "HUAXI Hole 1" versus without the "HUAXI Hole 1". The study aims to evaluate differences in operative efficiency, surgical safety, postoperative aesthetics, and oncological safety between the two groups.

NCT Number	NCT06995118
Lead Sponsor	Du Zhenggui Collaborators: West China Tianfu Hospital, West China Fourth Hospital, Fourth People's Hospital of Sichuan Province, The First Affiliated Hospital of Zhengzhou University, The First Hospital of Jilin University, Shanxi Bethune Hospital, Chengdu Fifth People's Hospital, Suzhou Municipal Hospital, Taiyuan Central Hospital of Shanxi Medical University, The People's Hospital of DAZU ，Chongqing, Anyang City Tumor Hospital, Mianyang Hospital of Traditional Chinese Medicine, Sichuan Cancer Hospital and Research Institute, Deyang People's Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Guangzhou First People's Hospital, Fujian Medical University Union Hospital, Nanchang People's Hospital
Conditions	Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Enrollment	337 participants
Start Date	2025-06-17
Primary Completion	2026-06-01 (estimated)
Study Completion	2031-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-02