Evaluation of the Effectiveness and Safety of Laparoscopic Assisted Mastectomy With Preservation of Nipple and Areola, Immediate One-step Breast Reconstruction With Pectoral Muscle Prosthesis and Patch, and Simultaneous Autologous Fat Transplantation

June 17, 2025 updated by: Henan Cancer Hospital

To Evaluate the Efficacy and Safety of Laparoscopic-assisted Nipple-areola-sparing Mastectomy Plus Pectoral Anterior Prosthesis Plus Mesh Immediate One-step Breast Reconstruction Plus Concurrent Autologous Fat Grafting: a Prospective, Single-centre, Single-arm Study

Evaluation of the effectiveness and safety of laparoscopic assisted breast resection with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch for immediate one-step breast reconstruction and concurrent autologous fat transplantation in a prospective study

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, single center, single arm clinical trial. It is planned to recruit 29 patients with unilateral breast cancer of cT1-2N0M0. Patients who meet the inclusion criteria are planned to undergo laparoscopic assisted NSM+prosthesis combined with patch breast reconstruction and concurrent fat transplantation surgery.

Main endpoint of the study: incidence of severe complications after breast reconstruction surgery.

Secondary study endpoints: BREAST-Q (Breast Reconstruction Module) score, breast reconstruction success rate, incidence of all complications, physician evaluated breast cosmetic outcomes, occurrence of capsule contractures, nipple areola and breast skin sensation, and tumor safety.

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women aged 18 to 70 years old;
  2. In the first diagnosis of unilateral breast cancer patients, the maximum diameter of invasive tumor is ≤ 5cm, and there is no requirement for tumor size of carcinoma in situ in principle;
  3. Patients undergoing preventive mastectomy are not allowed to be included in the study;
  4. Clinical examination and auxiliary examinations suggest that the tumor is confined to the mammary gland and has not invaded the nipple areola complex, skin, or chest wall;
  5. Clinical axillary lymph node negative (clinical physical examination and imaging suggest negative axillary lymph nodes; for suspected positive axillary lymph nodes, fine needle aspiration or hollow needle biopsy is required to confirm negative);
  6. Sentinel lymph node biopsy negative;
  7. Patients with low load positive axillary lymph nodes (isolated tumor cells, micro or macro metastases), but exempted from adjuvant radiotherapy after surgery;
  8. Patients who are not suitable for breast conserving surgery or who are unwilling to undergo breast conserving surgery and plan to undergo laparoscopic assisted mastectomy with preservation of the nipple and areola, as well as immediate one-step breast reconstruction with a breast prosthesis combined with a chest muscle prosthesis and simultaneous fat transplantation; If frozen pathology or routine pathology indicates a positive posterior margin of the nipple, it is allowed to remove the nipple, but the areola must be preserved;
  9. The volume of the prosthesis is less than 500cc;
  10. During the observation period of the study, the affected side may consider re fat injection, but symmetrical surgery is not allowed on the healthy side;
  11. ECOG score 0-1 points;
  12. New adjuvant chemotherapy patients are allowed to be enrolled;
  13. No smoking history or quitting smoking for at least 4 weeks;
  14. The researcher determines that they are able to comply with the research protocol;
  15. Those who participate in other clinical trials (including intervention or non intervention studies) at the same time and are judged by the researchers to not affect the study protocol can be enrolled normally;
  16. After obtaining sufficient information, voluntarily participate and sign an informed consent form.

Exclusion Criteria:

  1. Specialized physical examination and/or auxiliary examination suggest that the tumor involves the nipple areola complex (including Paget's disease) or the skin;
  2. Double breast cancer;
  3. Bilateral breast reconstruction patients;
  4. Patients who have undergone fat injection, breast augmentation with implants, and breast reduction surgery in the past;
  5. Patients with incomplete immune function, poor control of diabetes and active smoking;
  6. Patients with severe breast sagging;
  7. Breast cup size ≥ E;
  8. Accept two-step breast reconstruction using dilators/prostheses, autologous breast reconstruction, and breast reconstruction performed through open surgery;
  9. Patients who have previously received and/or received postoperative radiotherapy for the reconstruction site or chest wall;
  10. Patients who plan to undergo symmetrical surgery on the healthy breast during the visit period;
  11. Patients with mental illnesses or abnormalities who are expected to be unable to independently complete the BREAST-Q scale;
  12. Pregnant and lactating patients;
  13. Poor compliance, unable to conduct relevant examinations and follow ups according to the trial requirements;
  14. Suffering from serious accompanying diseases or other comorbidities that may interfere with planned treatment, or any other circumstances that the researcher deems unsuitable for the patient to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation
Endoscopic assisted NSM+prosthesis combined with patch for anterior breast reconstruction and simultaneous fat transplantation
Procedure: Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation
Laparoscopic assisted mastectomy with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch, immediate one-step breast reconstruction and simultaneous autologous fat transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of serious complications after breast reconstruction surgery
Time Frame: One week after surgery, one month after surgery, three months after surgery, six months after surgery, and one year after surgery
All surgical related complications (including hematoma, poor wound healing, skin flap necrosis, infection, incision dehiscence, fat injection related complications, etc.) are classified according to the Clavien Dindo scoring system. The Clavien Dindo grading system is based on the severity of postoperative complications and whether corresponding treatment is needed for the complications. Postoperative complications are classified into grades I-V, and those classified as grade III or above by Clavien Dindo are considered serious complications.
One week after surgery, one month after surgery, three months after surgery, six months after surgery, and one year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BREAST-Q (Breast Reconstruction Module) score
Time Frame: BREAST-Q scoring was performed at preoperative, postoperative 1-month, 3-month, 6-month, and 12-month follow-up
This experiment obtained subject report results from four dimensions of breast satisfaction, psychological health, physical health, and sexual health using the BREAST-Q (Breast Reconstruction Module) scoring system. BREAST-Q scoring was performed at preoperative, 1 month, 3 months, 6 months, and 12-month follow-up. The BREAST-Q score at 12 months after surgery is the main evaluation metric.
BREAST-Q scoring was performed at preoperative, postoperative 1-month, 3-month, 6-month, and 12-month follow-up
Success rate of breast reconstruction
Time Frame: One year after surgery
Calculation formula:The result of subtracting the number of implant removal cases caused by complications from the total number of breast reconstruction cases received, divided by the total number of reconstruction cases received.Definition of implant removal caused by complications: Refers to the removal of implants during the 12-month follow-up period due to surgical related reasons such as hematoma, serum swelling, skin flap necrosis, nipple areola necrosis, infection, incision dehiscence, implant exposure, capsule contraction, and prosthesis displacement.
One year after surgery
All incidence of complications
Time Frame: On the day of surgery, one week after surgery, one month after surgery, three months after surgery, six months after surgery, and one year after surgery
Complications such as hematoma, poor wound healing, skin flap necrosis, infection, incision dehiscence, and fat injection related complications are classified according to the Clavien Dindo scoring system, including grades I-V, and evaluated and recorded.
On the day of surgery, one week after surgery, one month after surgery, three months after surgery, six months after surgery, and one year after surgery
Breast cosmetic effects evaluated by doctors
Time Frame: Before surgery，on the day of surgery, one months after surgery,three months after surgery, six months after surgery, and one year after surgery
The cosmetic effect of breast reconstruction is evaluated by professional doctors independent of the surgeon using the ueda scoring criteria based on patient photos.
Before surgery，on the day of surgery, one months after surgery,three months after surgery, six months after surgery, and one year after surgery
Occurrence of capsule contraction
Time Frame: one months after surgery,three months after surgery, six months after surgery, and one year after surgery
The Baker classification method (Spear&Baker, 1995) was used for evaluation.
one months after surgery,three months after surgery, six months after surgery, and one year after surgery
Nipple, areola, and breast skin sensation
Time Frame: Before surgery, one week after surgery, one months after surgery,three months after surgery, six months after surgery, and one year after surgery
The Semmes Weinstein single filament inspection method was used to measure tactile sensation. Semmes Weinstein Monofilament Inspection Method
Before surgery, one week after surgery, one months after surgery,three months after surgery, six months after surgery, and one year after surgery
Tumor safety
Time Frame: five years after surgery
Disease free survival (DFS) and overall survival (OS). DFS defines the time from surgery to the occurrence of recurrence, metastasis, or last follow-up. OS defines the time from surgery to patient death or last follow-up.
five years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Investigators

  • Study Director: xiuchun chen, Henan Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

June 17, 2025

First Submitted That Met QC Criteria

June 17, 2025

First Posted (Estimated)

June 25, 2025

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 17, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-362

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer Patients

Clinical Trials on Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe