The Comparison Between DEDTI BR and T/E BR (DETE-BR)
11 de mayo de 2026 actualizado por: Du Zhenggui, West China Hospital
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
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
412
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Zhenggui Du
- Número de teléfono: +86 13880768222
- Correo electrónico: docduzg@163.com
Ubicaciones de estudio
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Chengdu, Porcelana
- West China Hospital of Sichuan University
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Contacto:
- Zhenggui Du
- Número de teléfono: +86 13880768222
- Correo electrónico: docduzg@163.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: DEDTI group
Delayed endoscopic direct-to-implant breast reconstruction
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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.
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Experimental: T/E group
Two-stage expander-to-implant breast reconstruction
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Surgical complication rates
Periodo de tiempo: Postoperative 2 years
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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.
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Postoperative 2 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Operation time
Periodo de tiempo: Intraoperative
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The surgical time includes total anesthesia time, total operative time, and flap dissociation time.
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Intraoperative
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Number of operations
Periodo de tiempo: Intraoperative
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The number of surgical procedures performed, representing the total count of operations conducted.
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Intraoperative
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Contralateral breast adjustment operation rates
Periodo de tiempo: Intraoperative
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The rate of contralateral breast adjustment operations, defined as the proportion of patients who undergo additional surgical procedures to modify or adjust the contralateral (opposite) breast to achieve symmetry with the reconstructed breast.
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Intraoperative
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Surgery-related costs
Periodo de tiempo: Postoperative 1 month
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Surgery-related costs include total hospitalization expenses, surgical costs, postoperative dressing change costs, expander injection costs, etc.
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Postoperative 1 month
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Aesthetic outcomes (BREAST-Q score)
Periodo de tiempo: Postoperative 6 months and 2 years
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The BREAST-Q 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.
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Postoperative 6 months and 2 years
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Aesthetic outcome (SCAR-Q score)
Periodo de tiempo: Postoperative 6 months and 2 years
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A validated scar-specific patient-reported outcome measure tool for assessing the quality of life of patients with scars.
It consists of three independent scales: scar appearance, scar symptoms, and psychosocial impact.
Transformed scores range from 0 to 100, with higher scores indicating better outcomes.
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Postoperative 6 months and 2 years
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Aesthetic outcome (Harris score)
Periodo de tiempo: Postoperative 6 months and 2 years
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The Harris score was used to record the subjective judgment of symmetry of the reconstructed breast compared to the contralateral breast.
The results were categorized as excellent (treated breast nearly identical to untreated breast), good (treated breast slightly different than untreated), fair (treated breast clearly different than untreated), and poor (treated breast seriously distorted).
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Postoperative 6 months and 2 years
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Aesthetic outcome (Ueda score)
Periodo de tiempo: Postoperative 6 months and 2 years
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Doctor-reported aesthetic outcomes will be evaluated by three professional breast surgeons using the Ueda scale, based on postoperative photographs.
Scores range from 0 to 10 points, with higher values indicating better results.
The categorized as follows: Excellent (≥9 points), Good (7-8 points), Fair (5-6 points), Poor (≤4 points).
Both raw scores and categorizations will be documented.
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Postoperative 6 months and 2 years
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Quality of Life (EORTC Quality of Life scores)
Periodo de tiempo: Postoperative 6 months and 2 years
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EORTC Scores are a series of questionnaires developed by the European Organisation for Research and Treatment of Cancer (EORTC) to assess the health-related quality of life (HRQoL) of cancer patients.
These questionnaires are widely used in clinical trials and clinical practice to help evaluate treatment outcomes and patients' quality of life.
The scoring range is from 0 to 100.
A higher score in the functional domains indicates better functioning, while a higher score in the symptom domains indicates more severe symptoms.
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Postoperative 6 months and 2 years
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Implant-assisted complications
Periodo de tiempo: Postoperative 6 months and 2 years
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Implant-assisted complication rates, including rippling, prosthesis outline appearance, capsular contraction, prosthesis rotation.
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Postoperative 6 months and 2 years
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Divorce rates
Periodo de tiempo: Postoperative 6 months and 2 years
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Divorce rates
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Postoperative 6 months and 2 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de mayo de 2026
Finalización primaria (Estimado)
31 de diciembre de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
20 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de mayo de 2026
Publicado por primera vez (Actual)
18 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de mayo de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025 (1442)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Qualified researchers can request access to anonymized individual patient-level data via the request portal.
All IPD requests should be emailed to Dr. Zhenggui Du, the general project leader, and will be evaluated by Dr. Du and the head of the collaborating organization to decide whether to approve.
Marco de tiempo para compartir IPD
After publication of relevant research outputs, such as academic papers and books
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .