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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Aesthetic outcome evaluation--BREAST-Q scores
研究概览
简要总结
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.
详细描述
This study is a multicenter, open, prospective cohort study. Inclusion criteria: (1) Female patients aged 18 - 70 years (inclusive) who have undergone simple mastectomy for breast cancer; (2) Patients with good local flap viability and laxity one year after total mastectomy or six months after completion of radiotherapy; (3) Patients who are able and willing to sign the informed consent form.
Exclusion criteria: (1) Recurrence detected on follow-up (based on clinical, imaging, or pathological findings), including local/regional recurrence or uncontrollable distant metastasis; (2) Patients who had the pectoralis major muscle resected during the initial mastectomy; (3) History of thoracic or back surgery with suspected damage to the thoracodorsal vessels; (4) Poor general condition and inability to tolerate surgery; (5) 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; (6) Participation in other clinical studies that may interfere with this trial.
Prior to group allocation, investigators at each research center will first stratify the subjects by radiotherapy. The subjects will be divided into two groups based on whether they have received radiotherapy, with the sample size ratio of the radiotherapy group to the non-radiotherapy group being 1:2. Subsequently, the subjects will be assigned to the two-stage endoscopic immediate prosthesis breast reconstruction group (with a proportion of "3") and the latissimus dorsi±prosthesis breast reconstruction group (with a proportion of "1"). The target sample size is 268 participants, comprising 89 in the radiotherapy group (67 in the two-stage endoscopic immediate prosthesis breast reconstruction group, 22 in the latissimus dorsi±prosthesis breast reconstruction group) and 179 in the non-radiotherapy group (134 in the two-stage endoscopic immediate prosthesis breast reconstruction group, 45 in the latissimus dorsi±prosthesis breast reconstruction group).
Collecting data includes encompassing demographics (e.g., age, BMI, breast ptosis), medical history (e.g., comorbidities, prior surgeries, family cancer history), oncological profiles (e.g., tumor type, size, location, stage, immunohistochemistry, nodal status, neoadjuvant/adjuvant therapies), and surgical details (e.g., procedure type, operative time, intraoperative blood loss, margin status, gland resection weight, implant size, drainage placement) from preoperatively to postoperatively. Postoperative follow-ups at 1 month, 6 months, 1 year will document complications, cosmesis (BREAST-Q, SCAR-Q, QLQ-BR45, Harris and Ueda assessments). Complications are recorded per patient, with events classified as major, minor, or any using the Clavien-Dindo grading system (Grades I-II: minor; III-IV: major). BREAST-Q/SCAR-Q/QLQ-BR45 questionnaires will be completed preoperatively and at 6 months/12 months postoperatively, alongside Harris and Ueda assessments and standardized breast photography (anteroposterior, lateral, oblique views).
An interim analysis will occur 1 year after study initiation and 1 month post-enrollment completion. Final analysis follows 1-year postoperative follow-up for all participants. Categorical variables will be analyzed using chi-square or Fisher's exact tests; continuous variables via t-tests, ANOVA, or non-parametric alternatives (Mann-Whitney/Kruskal-Wallis) as appropriate. Survival outcomes will employ Kaplan-Meier curves with log-rank testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group 1
Delayed Endoscopic DTI Breast Reconstruction
干预措施: Surgery options (Procedure)
Control group 2
Latissimus dorsi ± impalnt Breast Reconstruction
干预措施: Surgery options (Procedure)
结局指标
主要结局
Aesthetic outcome evaluation--BREAST-Q scores
时间窗: Preoperative (baseline), 1-year postoperative
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
次要结局
- Complications(1 year postoperative)
- Surgical time(Intraoperative)
- surgical-related costs(perioperative)
- the rate of contralateral breast adjustment surgery(perioperative)
- Quality of Life--BREAST-Q scores(1 year postoperative)
- Aesthetic outcome evaluation--Harris score(1-year postoperative)
- Aesthetic outcome evaluation--Ueda score(1-year postoperative)
- Quality of Life--EORTC Quality of Life scores(1-year postoperative)
- Scar assessment--SCAR-Q scales(1-year postoperative)
- Aesthetic outcome evaluation--aesthetic complications(1-year postoperative)
研究者
Du Zhenggui
Clinical Professor
West China Hospital