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A Comparative Study of Delayed Endoscopic DTI and Latissimus Dorsi ±Impalnt Reconstruction Post-Mastectomy

NCT07757074 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 268

Last updated 2026-08-11

No results posted yet for this study

Summary

Breast cancer is the most common malignancy in women. In 2022, China saw about 357,200 new cases and 75,000 deaths, accounting for 15.59% and 7.94% of all new cancer cases and cancer-related deaths, respectively. Factors like physician skills, patient attitudes, economics, and tumor-related issues have led to a breast-conserving rate of about 19.5% nationwide, and less than 10% in non-first-tier cities. The immediate breast reconstruction rate after mastectomy is around 10.7%, with over 70% of patients losing their breasts during initial surgery. These patients often face long-term suboptimal psychological health post-surgery. As treatment outcomes improve, more patients are seeking delayed breast reconstruction.

Breast reconstruction after simple mastectomy faces challenges due to insufficient skin and tissue volume. Traditional methods include: (1) A two - stage procedure with a tissue expander in the first stage and prosthesis replacement in the second stage. This approach increases costs, requires two surgeries and anesthetics, and carries higher risks of incision dehiscence, prosthesis exposure, infection, and surgical failure. (2) Autologous reconstruction using the latissimus dorsi muscle flap, which involves simultaneous surgery on donor and recipient sites. This method results in significant trauma, longer operating times, higher complication risks, compromised sensation and function, large scars, and potential shoulder - related issues. Due to limited tissue volume, a prosthesis is often needed. While autologous reconstruction offers better breast satisfaction and social psychological health, its complexity and costs limit patient acceptance.

To tackle these challenges, our team has developed a minimally invasive, two - stage endoscopic breast reconstruction technique via an axillary approach with an inflation method. This approach reduces surgical time, trauma, and costs, minimizes complications, and enables faster recovery. The tension - free axillary incision eliminates the risk of dehiscence. Skin expansion through the prosthesis cavity results in a more natural - looking and softer breast. No studies have compared this technique with latissimus dorsi ± prosthesis reconstruction after simple mastectomy. We propose a prospective cohort study to evaluate its safety and feasibility, aiming to offer a more cost - effective, simple, and efficient reconstruction option to improve patients' quality of life.

Conditions

Interventions

PROCEDURE

Surgery options

The different surgery options for patients Post-Mastectomy

Sponsors & Collaborators

  • West China Hospital

    collaborator OTHER

  • West China Second Hospital, Sichuan University

    collaborator UNKNOWN

  • Fourth People's Hospital of Sichuan Province

    collaborator OTHER

  • The Second People's Hospital of Chengdu

    collaborator OTHER

  • Suzhou Municipal Hospital

    collaborator OTHER

  • Du Zhenggui

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-09-30
Completion
2028-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757074 on ClinicalTrials.gov