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RecruitingNot ApplicableNCT06995118

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

The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction: A National Multicenter, Open-Label, Randomized Controlled Trial (HUAXI-h-01)

Sponsor

Du Zhenggui

Enrollment

337 participants

Start Date

Jun 17, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a new surgical approach for nipple-sparing mastectomy (breast removal while preserving the nipple) with immediate implant reconstruction, performed using small incisions and an endoscope (camera). The goal is to assess how well this minimally invasive technique works and how it affects patient outcomes. **You may be eligible if...** - You are a woman aged 18 to 70 - You have breast cancer (such as DCIS or invasive breast cancer) or are having a preventive mastectomy - Your tumor is 5 cm or smaller, with no spread to the nipple, skin, or chest wall - You are eligible for nipple-sparing mastectomy with implant reconstruction **You may NOT be eligible if...** - You had open breast surgery in the past year - You were diagnosed with breast cancer during pregnancy or breastfeeding - You have had radiation that scarred the nipple area - Your cancer has spread to other parts of the body - Your BMI is 40 or higher, your blood sugar is poorly controlled (HbA1c over 7.5%), or you smoke more than a pack a day Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHUAXI hole 1

A small incision of 2mm is made at the junction of the upper outer edge of the areola and the skin, through which the scalpel is placed to assist in the resection of breast glands in reverse-sequence nipple-sparing mastectomy and direct-to-implant breast reconstruction.

Locations(20)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Anyang City Tumor Hospital

Anyang, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The First Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, China

The Affiliated Hospital of lnner Mongolia Medical University

Hohhot, Inner Mongolia, China

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Nanchang People's Hospital

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Taiyuan Central Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

The Fourth People's Hospital of Sichuan Province

Chengdu, Sichuan, China

Chengdu Fifth People's Hospital

Chengdu, Sichuan, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

West China hospital of Sichuan University

Chengdu, Sichuan, China

West China School of Public Health and West China Fourth Hospital, Sichuan University

Chengdu, Sichuan, China

West China Tianfu Hospital

Chengdu, Sichuan, China

Deyang People's Hospital

Deyang, Sichuan, China

Mianyang Hospital of Traditional Chinese Medicine

Mianyang, Sichuan, China

The People's Hospital of Dazu, Chongqing

Chongqing, China

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NCT06995118

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