Clinical trial · Observational
A Comparative Study of Delayed Endoscopic DTI and Latissimus Dorsi ±Impalnt Reconstruction Post-Mastectomy
A National Multicenter, Prospective Cohort Study on Delayed Endoscopic Direct-to-Implant Breast Reconstruction Via Transaxillary Approach Versus Latissimus Dorsi ± Implant Breast Reconstruction Following Mastectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery options | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control group 1
- description
- Delayed Endoscopic DTI Breast Reconstruction
- interventionNames
- Procedure: Surgery options
- label
- Control group 2
- description
- Latissimus dorsi ± impalnt Breast Reconstruction
- interventionNames
- Procedure: Surgery options
Primary outcomes (1)
- measure
- Aesthetic outcome evaluation--BREAST-Q scores
- timeFrame
- Preoperative (baseline), 1-year postoperative
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (10)
- BACKGROUNDSantosa 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
- BACKGROUNDBennett 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
- BACKGROUNDJagsi 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
- BACKGROUNDRen 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
- BACKGROUNDMin 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
- BACKGROUNDMovassaghi 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
- BACKGROUNDYang 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.