Clinical trials

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.

This study is a multicenter, open-label, randomized controlled trial. The study aims to evaluate differences in operative efficiency (e.g., operative time), economic effect, surgical safety (e.g., surgical complication rates), postoperative aesthetics (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores and Ueda scores), and oncological safety (e.g., margin status, no local recurrence survival) between patients undergoing M-E-BCS and patients undergoing C-O-BCS.

This study is a nationwide multicenter, single-arm, retrospective study. The study aims to conduct a detailed analysis of operation-related parameters, aesthetic outcomes (e.g., BREAST-Q scores and Harris scores), and safety (e.g., surgical complication rates) in delayed endoscopic direct-to-implant breast reconstruction via the axillary approach.

Breast cancer is a malignant tumor that seriously threatens the health of women, with an increasing incidence rate. The current main treatment methods include multidisciplinary diagnosis and treatment such as surgery, radiotherapy, chemotherapy, and endocrine therapy, among which surgery is the key. Postoperative care is also very important. Traditional breast surgery requires long-term placement of drainage tubes after the operation. However, long-term placement of drainage tubes increases the incidence of postoperative complications such as infection and delayed wound healing, prolongs hospital stays, increases economic burden, and also affects the aesthetic outcome. Our team has innovatively adopted the "reverse-sequence" endoscopic nipple-sparing-mastectomy with direct-to-implant breast reconstruction. This method is highly efficient and safe, with no incisions on the surface of the breast, reducing the risk of incision dehiscence and the probability of flap ischemia and necrosis. Based on this, our team proposes to appropriately relax the drainage criteria and remove the drainage tube earlier under the premise of ensuring the sterility of the effusion, and preliminary findings show that patients have better postoperative aesthetic outcomes, with a lower incidence of flap infection, ischemia, and necrosis than expected, and the degree of breast deformation caused by radiotherapy is also reduced. However, there is still controversy over the pros and cons of drainage criteria. Some scholars believe that strict drainage criteria can reduce the risk of infection and implant displacement, and plastic surgeons are more concerned about the impact of long-term tube placement on aesthetic outcomes and quality of life. Currently there is a lack of large sample, multicenter, randomized controlled studies to provide high - level evidence. Therefore, our team plans to conduct a national multicenter, open, randomized controlled study to compare the advantages and disadvantages of the two drainage methods under the premise of not reducing postoperative surgical and oncological safety, in order to explore the optimal timing for drain removal and improve patients' satisfaction with the reconstructed breast.

This study is a multicenter, open-label, randomized controlled trial. It will prospectively compare outcomes between patients undergoing reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) with the "HUAXI Hole 1" versus without the "HUAXI Hole 1". The study aims to evaluate differences in operative efficiency, surgical safety, postoperative aesthetics, and oncological safety between the two groups.