The Comparison Between DEDTI BR and T/E BR

NCT07593846 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2025 (1442)
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

Brief Summary

This is a national multicenter, prospective, cohort study. The study aims to compare surgical safety (e.g., surgical complication rates), surgery-related indicators (e.g., operation time, number of operations, surgery-related costs, contralateral breast adjustment operation rates), aesthetic outcomes (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores, Ueda scores and QLQ-BR45 scores), and divorce rate between patients undergoing delayed endoscopic direct-to-implant breast reconstruction via an axillary approach and those undergoing the two-stage expander-to-implant breast reconstruction following simple mastectomy.

Conditions

Breast Cancer

Keywords

Breast Cancer; Endoscopic surgery; Minimal invasive surgery; Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• Surgical complication rates

  Surgical complication rates, major complication rates and minor complication rates, including flap scald, NAC ischemia/necrosis, seroma, surgical area infection, bleeding, incision splitting, flap ischemia/necrosis.

  Postoperative 2 years

Secondary Outcomes (11)

• Operation time

  Intraoperative

• Number of operations

  Intraoperative

• Contralateral breast adjustment operation rates

  Intraoperative

• Surgery-related costs

  Postoperative 1 month

• Aesthetic outcomes (BREAST-Q score)

  Postoperative 6 months and 2 years

Study Arms (2)

DEDTI group

EXPERIMENTAL

Delayed endoscopic direct-to-implant breast reconstruction

Procedure: Delayed endoscopic direct-to-implant breast reconstruction

T/E group

EXPERIMENTAL

Two-stage expander-to-implant breast reconstruction

Procedure: Two-stage expander-to-implant breast reconstruction

Interventions

Delayed endoscopic direct-to-implant breast reconstruction PROCEDURE

This technique allows for breast reconstruction in a single operation. Taking dual-plane breast reconstruction as an example, preoperative marking lines are drawn to indicate the contour and inframammary fold of the reconstructed breast. A 4-5 cm axillary incision is placed one finger-breadth below the axillary apex. After making the skin incision, the plane between the pectoralis major and minor muscles is identified and dissected, extending approximately 2 cm below the previous mastectomy horizontal scar. The inner and lower parts of the pectoralis major muscle were then separated. Proceed to the subcutaneous layer and continue to dissociate the flap until it reaches the pre-designed folds and the breast boundary. The use of the TiLOOP® Bra depends on the thickness of the patient's flap. Finally, the prosthesis is placed behind the pectoralis major muscle for breast reconstruction.

DEDTI group

Two-stage expander-to-implant breast reconstruction PROCEDURE

The two-stage expander-to-implant breast reconstruction involves initially placing a tissue expander to stretch the skin. Once the skin has sufficient capacity, a second surgery is performed to replace the expander with a breast implant. The expander can be gradually adjusted based on the patient's skin expansion progress, physical recovery, and aesthetic needs to achieve optimal reconstruction results.

T/E group

Eligibility Criteria

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

You may qualify if:

• Female patients aged 18-70 years (inclusive) who have undergone simple mastectomy for breast cancer;
• At least 1 year after simple mastectomy or 6 months after completion of radiotherapy, with good local skin viability and skin laxity;
• Voluntary provision of informed consent.

You may not qualify if:

• Local/regional recurrence or uncontrolled distant metastasis detected upon re-examination (clinical, imaging, or pathological evidence);
• Pectoralis major muscle was resected during the initial surgery;
• Preoperative severe comorbidities with poor general condition, rendering the patient unable to tolerate surgery;
• Immunodeficiency;
• Long-term smoking history or poorly controlled diabetes mellitus;
• Currently participating in other clinical trials that may affect the results of this study.

Sponsors & Collaborators

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

Study Sites (1)

West China hospital of Sichuan University

Chengdu, China

Location

Related Publications (11)

• Di Giuli R, Cavallero MF, Ferrari C, Vaccari S, Bucci F, Bandi V, Klinger FM, Vinci V. Two-stage prepectoral breast reconstruction: A comprehensive review and meta-analysis. J Plast Reconstr Aesthet Surg. 2025 May;104:388-397. doi: 10.1016/j.bjps.2025.02.041. Epub 2025 Feb 25.

  PMID: 40168922 RESULT

• 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 RESULT

• 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 RESULT

• Atiyeh B, Chahine FM. Two-Stage Implant-Based Breast Reconstruction: An Evolution of the Conceptual and Technical Approach over a Two-Decade Period. Plast Reconstr Surg. 2017 Jul;140(1):227e-228e. doi: 10.1097/PRS.0000000000003467. No abstract available.

  PMID: 28272276 RESULT

• Cordeiro PG, McCarthy CM. A single surgeon's 12-year experience with tissue expander/implant breast reconstruction: part I. A prospective analysis of early complications. Plast Reconstr Surg. 2006 Sep 15;118(4):825-831. doi: 10.1097/01.prs.0000232362.82402.e8.

  PMID: 16980842 RESULT

• Dikmans RE, Negenborn VL, Bouman MB, Winters HA, Twisk JW, Ruhe PQ, Mureau MA, Smit JM, Tuinder S, Eltahir Y, Posch NA, van Steveninck-Barends JM, Meesters-Caberg MA, van der Hulst RR, Ritt MJ, Mullender MG. Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial. Lancet Oncol. 2017 Feb;18(2):251-258. doi: 10.1016/S1470-2045(16)30668-4. Epub 2016 Dec 22.

  PMID: 28012977 RESULT

• Bellini E, Pesce M, Santi P, Raposio E. Two-Stage Tissue-Expander Breast Reconstruction: A Focus on the Surgical Technique. Biomed Res Int. 2017;2017:1791546. doi: 10.1155/2017/1791546. Epub 2017 Dec 10.

  PMID: 29376067 RESULT

• Ostapenko E, Nixdorf L, Devyatko Y, Exner R, Wimmer K, Fitzal F. Prepectoral Versus Subpectoral Implant-Based Breast Reconstruction: A Systemic Review and Meta-analysis. Ann Surg Oncol. 2023 Jan;30(1):126-136. doi: 10.1245/s10434-022-12567-0. Epub 2022 Oct 16.

  PMID: 36245049 RESULT

• Yin Z, Wang Y, Sun J, Huang Q, Liu J, He S, Han C, Wang S, Ding B, Yin J. Association of sociodemographic and oncological features with decision on implant-based versus autologous immediate postmastectomy breast reconstruction in Chinese patients. Cancer Med. 2019 May;8(5):2223-2232. doi: 10.1002/cam4.2133. Epub 2019 Apr 5.

  PMID: 30950238 RESULT

• 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 RESULT

• 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 RESULT

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: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deputy director

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 18, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-04

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)