The Comparison Between DEDTI BR and T/E BR

Official title

A National Multicenter, Prospective, Cohort Study Comparing Delayed Endoscopic Direct-to-Implant Breast Reconstruction Via Axillary Approach With the Two-Stage Expander-to-Implant Breast Reconstruction Following Simple Mastectomy

Overview

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.

Detailed description

Breast cancer is one of the most prevalent malignant tumors among women, with comprehensive treatment primarily centered around surgery being the mainstay approach. Mastectomy accounts for 88.8% of primary breast cancer surgeries, yet the rate of immediate breast reconstruction is only about 10.7%, resulting in the majority of patients losing their breasts at the time of initial surgery and suffering from long-term suboptimal psychosocial health, with divorce rates reaching as high as 40%. With the improvement in breast cancer treatment outcomes, an increasing number of women hope to improve postoperative breast morphology and alleviate psychological trauma through breast reconstruction. Traditional reconstruction methods include autologous tissue reconstruction and prosthetic reconstruction. The former involves significant trauma and a high incidence of complications, while the latter often requires a two-stage approach due to insufficient skin tissue, involving initial placement of a tissue expander followed by replacement with a prosthetic implant, which increases the number of surgeries and the risk of complications.

To address this issue, our team has developed a novel delayed endoscopic direct-to-implant breast reconstruction technique via an axillary incision approach with insufflation, which requires only a single surgery, significantly reducing surgical time, trauma, and costs, as well as the incidence of complications. Postoperatively, there are no fresh incisions on the breast, resulting in a more natural appearance and softer feel. This study aims to compare this technique with the traditional two-stage approach, exploring postoperative complications, aesthetic outcomes, quality of life, cost-effectiveness, and surgical-related indicators. To comprehensively evaluate its clinical benefits, large-scale multicenter studies are required to provide evidence-based medical evidence and optimize surgical strategies.

Therefore, this national multicenter, prospective, cohort study will 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.

Interventions

• Procedure Delayed endoscopic direct-to-implant breast reconstruction
  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 hori
• Procedure Two-stage expander-to-implant breast reconstruction
  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.

Primary outcome measures

• Surgical complication rates [Time frame: Postoperative 2 years]

Secondary outcome measures (11)

• Operation time [Time frame: Intraoperative]
• Number of operations [Time frame: Intraoperative]
• Contralateral breast adjustment operation rates [Time frame: Intraoperative]
• Surgery-related costs [Time frame: Postoperative 1 month]
• Aesthetic outcomes (BREAST-Q score) [Time frame: Postoperative 6 months and 2 years]
• Aesthetic outcome (SCAR-Q score) [Time frame: Postoperative 6 months and 2 years]
• Aesthetic outcome (Harris score) [Time frame: Postoperative 6 months and 2 years]
• Aesthetic outcome (Ueda score) [Time frame: Postoperative 6 months and 2 years]
• Quality of Life (EORTC Quality of Life scores) [Time frame: Postoperative 6 months and 2 years]
• Implant-assisted complications [Time frame: Postoperative 6 months and 2 years]
• Divorce rates [Time frame: Postoperative 6 months and 2 years]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• West China hospital of Sichuan University — Chengdu

Publications

• 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
• 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
• 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
• 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
• 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
• 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, multicent PMID 28012977
• 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
• 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

Identifiers

NCT: NCT07593846 · 2025 (1442)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗