Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT06995118
Status:
RECRUITING
Last Update Posted:
2025-07-02
First Post:
2025-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction
Sponsor:
Du Zhenggui
Organization:
Study Overview
Official Title:
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)
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HUAXI-h-01
Brief 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.
Detailed Description:
Conventional open nipple-sparing mastectomy (NSM) often results in significant surgical scarring, which is detrimental to the aesthetic outcome of the breast and the patient's psychosocial well-being. Meanwhile, endoscopic NSM has been reported to achieve favorable aesthetic outcomes and surgical safety. However, traditional endoscopic NSM has high technical difficulty and low surgical efficiency.
Our team has developed an innovative reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) following extensive research and clinical practice. This pioneering technique leverages the expansive force of gas to form a universal retractor. It employs an innovative reverse dissection sequence from deep to superficial layers, which retains the advantages of traditional endoscopic NSM while significantly improving operative efficiency. However, gland resection in the lower and inner quadrant of the breast remains technically challenging due to the long working distance and complex manipulation, often resulting in prolonged operative time and risks of incomplete gland resection.
To address these limitations, the West China Hospital team developed the "HUAXI Hole 1" technique-a 2-mm auxiliary incision at the superolateral edge of the areola, through which the electric scalpel is inserted to assist the gland resection. It can significantly reduce interference between instruments caused by the transaxillary single-incision approach and facilitate complete gland resection, which may contribute to improved surgical efficiency, surgical safety, and oncologic safety with the aesthetic advantages of the endoscopic technique. However, some researchers are concerned about the risks, such as nipple and areola complex (NAC) ischemia/necrosis, incision dehiscence, and surgical site infection. The prospective clinical evidence validating its efficacy and safety is currently lacking.
Therefore, this national multicenter, open-label, randomized controlled trial 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.
Our team has developed an innovative reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) following extensive research and clinical practice. This pioneering technique leverages the expansive force of gas to form a universal retractor. It employs an innovative reverse dissection sequence from deep to superficial layers, which retains the advantages of traditional endoscopic NSM while significantly improving operative efficiency. However, gland resection in the lower and inner quadrant of the breast remains technically challenging due to the long working distance and complex manipulation, often resulting in prolonged operative time and risks of incomplete gland resection.
To address these limitations, the West China Hospital team developed the "HUAXI Hole 1" technique-a 2-mm auxiliary incision at the superolateral edge of the areola, through which the electric scalpel is inserted to assist the gland resection. It can significantly reduce interference between instruments caused by the transaxillary single-incision approach and facilitate complete gland resection, which may contribute to improved surgical efficiency, surgical safety, and oncologic safety with the aesthetic advantages of the endoscopic technique. However, some researchers are concerned about the risks, such as nipple and areola complex (NAC) ischemia/necrosis, incision dehiscence, and surgical site infection. The prospective clinical evidence validating its efficacy and safety is currently lacking.
Therefore, this national multicenter, open-label, randomized controlled trial 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: