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

NCT07757074 | Not Yet Recruiting DMC

• 1 other identifier: 2025（1441）
• Study Type: observational
• Target: 268
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Breast Cancer; delayed Endoscopic DTI

Outcome Measures

Primary Outcomes (1)

• Aesthetic outcome evaluation--BREAST-Q scores

  The Satisfaction with Breasts module of BREAST-Q questionnaire is utilized to assess patient-reported aesthetic outcomes. Transformed scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores

  Preoperative (baseline), 1-year postoperative

Secondary Outcomes (10)

• Complications

  1 year postoperative

• Surgical time

  Intraoperative

• surgical-related costs

  perioperative

• the rate of contralateral breast adjustment surgery

  perioperative

• Quality of Life--BREAST-Q scores

  1 year postoperative

Study Arms (2)

Control group 1

Delayed Endoscopic DTI Breast Reconstruction

Procedure: Surgery options

Control group 2

Latissimus dorsi ± impalnt Breast Reconstruction

Procedure: Surgery options

Interventions

Surgery options PROCEDURE

The different surgery options for patients Post-Mastectomy

Control group 1; Control group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Collecting the data of breast cancer patients who visited our hospital and the cooperative units from 2026 to 2027.

You may qualify if:

• Female patients aged 18 - 70 years (inclusive) who have undergone simple mastectomy for breast cancer;
• Patients with good local flap viability and laxity one year after total mastectomy or six months after completion of radiotherapy;
• Patients who are able and willing to sign the informed consent form.

You may not qualify if:

• Recurrence detected on follow-up (based on clinical, imaging, or pathological findings), including local/regional recurrence or uncontrollable distant metastasis;
• Patients who had the pectoralis major muscle resected during the initial mastectomy;
• History of thoracic or back surgery with suspected damage to the thoracodorsal vessels;
• Poor general condition and inability to tolerate surgery;
• Presence of severe comorbidities, such as uncontrolled diabetes, severe bone marrow suppression after breast cancer treatment, compromised immune function, or a history of long-term smoking;
• Participation in other clinical studies that may interfere with this trial.

Sponsors & Collaborators

• Du Zhenggui: lead
• West China Hospital: collaborator
• West China Second Hospital, Sichuan University: collaborator
• Fourth People's Hospital of Sichuan Province: collaborator
• The Second People's Hospital of Chengdu: collaborator
• Suzhou Municipal Hospital: collaborator

Study Sites (1)

West China hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location

Related Publications (10)

• Santosa KB, Qi J, Kim HM, Hamill JB, Wilkins EG, Pusic AL. Long-term Patient-Reported Outcomes in Postmastectomy Breast Reconstruction. JAMA Surg. 2018 Oct 1;153(10):891-899. doi: 10.1001/jamasurg.2018.1677.

  PMID: 29926096 BACKGROUND

• Bennett KG, Qi J, Kim HM, Hamill JB, Pusic AL, Wilkins EG. Comparison of 2-Year Complication Rates Among Common Techniques for Postmastectomy Breast Reconstruction. JAMA Surg. 2018 Oct 1;153(10):901-908. doi: 10.1001/jamasurg.2018.1687.

  PMID: 29926077 BACKGROUND

• Jagsi R, Jiang J, Momoh AO, Alderman A, Giordano SH, Buchholz TA, Pierce LJ, Kronowitz SJ, Smith BD. Complications After Mastectomy and Immediate Breast Reconstruction for Breast Cancer: A Claims-Based Analysis. Ann Surg. 2016 Feb;263(2):219-27. doi: 10.1097/SLA.0000000000001177.

  PMID: 25876011 BACKGROUND

• Ren Y, Yu Y, Xu K, Li Z, Wang X. Meta-Analysis of Immediate Implant-Based Breast Reconstruction Versus Autologous Breast Reconstruction in the Setting of PMRT. Aesthetic Plast Surg. 2024 May;48(10):1940-1948. doi: 10.1007/s00266-023-03430-y. Epub 2023 Jun 28.

  PMID: 37380747 BACKGROUND

• Min K, Jeon DN, Han HH, Kim EK, Eom JS. Inframammary Fold Approach for Second-stage Operation in Expander-Implant Breast Reconstruction. Ann Plast Surg. 2021 Nov 1;87(5):501-505. doi: 10.1097/SAP.0000000000002629.

  PMID: 33346535 BACKGROUND

• Movassaghi K, Gilson A, Stewart CN, Cusic J, Movassaghi A. Prepectoral Two-Stage Implant-Based Breast Reconstruction with Poly-4-Hydroxybutyrate for Pocket Control without the Use of Acellular Dermal Matrix: A 4-Year Review. Plast Reconstr Surg. 2024 Jul 1;154(1):15-24. doi: 10.1097/PRS.0000000000010914. Epub 2023 Jul 6.

  PMID: 37410610 BACKGROUND

• Yang B, Ren G, Song E, Pan D, Zhang J, Wang Y, Liao N, Tang J, Wang X, Cui S, Jin F, Geng C, Sun Q, Li H, Fan Z, Cao X, Wang H, Wang S, Shao Z, Wu J. Current Status and Factors Influencing Surgical Options for Breast Cancer in China: A Nationwide Cross-Sectional Survey of 110 Hospitals. Oncologist. 2020 Oct;25(10):e1473-e1480. doi: 10.1634/theoncologist.2020-0001. Epub 2020 May 13.

  PMID: 32333626 BACKGROUND

• Zhao R, Jin M, Gao J, Zhang L, Tao L, Bao X. A Cross-Sectional Study of Breast Cancer Surgery and the Cost Based on Data From 77 Chinese 3A Hospitals in 2015. Front Oncol. 2022 Apr 26;12:857359. doi: 10.3389/fonc.2022.857359. eCollection 2022.

  PMID: 35558511 BACKGROUND

• Sun K, Zhang B, Lei S, Zheng R, Liang X, Li L, Feng X, Zhang S, Zeng H, Yao Y, Ma P, Wang S, Chen R, Han B, Wei W, He J. Incidence, mortality, and disability-adjusted life years of female breast cancer in China, 2022. Chin Med J (Engl). 2024 Oct 20;137(20):2429-2436. doi: 10.1097/CM9.0000000000003278. Epub 2024 Sep 5.

  PMID: 39238088 BACKGROUND

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zhenggui Du

CONTACT

+86 13880768222; docduzg@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication of relevant research outputs, such as academic papers and books
• Access Criteria: When a request has been approved, the investigator will provide access to the de-identified individual patient-level data in the data management platform (Electronic Data Capture, EDC). A signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing the requested information. Additionally, all users will need to accept the terms and conditions of the data management platform to gain access.

Locations

CN (1)