The Comparison Between DEDTI BR and T/E BR (DETE-BR)

May 11, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

412

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chengdu, China
        • West China Hospital of Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DEDTI group
Delayed endoscopic direct-to-implant breast reconstruction
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 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.
Experimental: T/E group
Two-stage expander-to-implant breast reconstruction
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical complication rates
Time Frame: Postoperative 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: Intraoperative
The surgical time includes total anesthesia time, total operative time, and flap dissociation time.
Intraoperative
Number of operations
Time Frame: Intraoperative
The number of surgical procedures performed, representing the total count of operations conducted.
Intraoperative
Contralateral breast adjustment operation rates
Time Frame: Intraoperative
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.
Intraoperative
Surgery-related costs
Time Frame: Postoperative 1 month
Surgery-related costs include total hospitalization expenses, surgical costs, postoperative dressing change costs, expander injection costs, etc.
Postoperative 1 month
Aesthetic outcomes (BREAST-Q score)
Time Frame: Postoperative 6 months and 2 years
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.
Postoperative 6 months and 2 years
Aesthetic outcome (SCAR-Q score)
Time Frame: Postoperative 6 months and 2 years
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.
Postoperative 6 months and 2 years
Aesthetic outcome (Harris score)
Time Frame: Postoperative 6 months and 2 years
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).
Postoperative 6 months and 2 years
Aesthetic outcome (Ueda score)
Time Frame: Postoperative 6 months and 2 years
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.
Postoperative 6 months and 2 years
Quality of Life (EORTC Quality of Life scores)
Time Frame: Postoperative 6 months and 2 years
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.
Postoperative 6 months and 2 years
Implant-assisted complications
Time Frame: Postoperative 6 months and 2 years
Implant-assisted complication rates, including rippling, prosthesis outline appearance, capsular contraction, prosthesis rotation.
Postoperative 6 months and 2 years
Divorce rates
Time Frame: Postoperative 6 months and 2 years
Divorce rates
Postoperative 6 months and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025 (1442)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After publication of relevant research outputs, such as academic papers and books

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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