[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Du Zhenggui\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":116},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,69,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100634427","the-comparison-between-m-e-bcs-and-c-o-bcs-100634427",false,"NCT07539545","The Comparison Between M-E-BCS and C-O-BCS.","A Comparative Study of Minimal Accessory-Incision-Assisted Endoscopic Breast-Conserving Surgery With Minimal Auxiliary Incisions Versus Conventional Open Breast-Conserving Surgery: A National Multicenter, Open-Label, Randomized Controlled Trial (MECO-BCS)","MECO","Inclusion Criteria:\n\n* female patients aged 18-70 years (inclusive);\n* preoperative pathological examination confirmed it as invasive breast cancer or ductal carcinoma in situ;\n* both clinical and imaging examinations clearly indicated that the lesion was a single lesion confined within the gland, without invasion of the skin, subcutaneous tissue, pectoralis major muscle, or the nipple-areola complex;\n* tumors in the inner and outer quadrants (three classification method, as shown in Figure 2);\n* preoperative tumor size ≤3 cm (pre-neoadjuvant chemotherapy if applicable);\n* the tumor is more than 2 cm away from the nipple (the distance is based on physical examination, with MRI and ultrasound as supplementary methods);\n* the patient has a clear intention to preserve the breast and can receive standard radiotherapy after the operation;\n* voluntary provision of informed consent. .\n\nExclusion Criteria:\n\n* clinically or radiologically evaluated as multifocal or multicentric breast cancer, with diffuse suspicious calcification, long spiculated masses, extensive local resection unable to obtain sufficient negative margins or ideal shape;\n* persistent positive tumor margins, and resection cannot ensure negative margins after resection;\n* inflammatory breast cancer;\n* pregnant and lactating women;\n* previous history of breast cancer surgery (including patients with recurrence after ipsilateral breast-conserving surgery);\n* breast cancer genetic gene mutations (such as BRCA1\u002F2 gene mutations);\n* preoperative severe underlying diseases that cannot tolerate general anesthesia and surgical procedures.\n* other situations that the researchers consider unsuitable for participation","FEMALE","18 Years","70 Years",{"count":21,"type":22},1366,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28],"Breast Cancer",[28,30,31,32],"Endoscopic surgery","Minimal invasive surgery","Breast-conserving Surgery","NOT_YET_RECRUITING","2026-04-13",{"date":36,"type":37},"2026-04-20","ACTUAL",{"date":39,"type":22},"2026-04-01",{"date":41,"type":22},"2032-12-31",{"name":43,"class":44},"Du Zhenggui","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":45},"100612701","a-nationwide-multicenter-single-arm-retrospective-study-of-delayed-endoscopic-dti-br-after-simple-mastectomy-100612701","NCT07257003","A Nationwide Multicenter, Single-arm, Retrospective Study of Delayed Endoscopic DTI-BR After Simple Mastectomy","A Nationwide Multicenter, Single-arm, Retrospective Study on Delayed Endoscopic Direct-to-implant Breast Reconstruction Via Axillary Approach After Simple Mastectomy in Breast Cancer Patients","DEDTI-BR","Inclusion Criteria:\n\n* Breast cancer patients who underwent delayed endoscopic direct-to-implant breast reconstruction after simple mastectomy at various centers from July 2024 to August 2025, all delayed endoscopic direct-to-implant breast reconstructions were performed ≥ 6 months after the initial mastectomy.\n\nExclusion Criteria:\n\n* Poor skin elasticity;\n* Re-evaluation (based on clinical, imaging, and pathological findings) indicates local or regional recurrence or uncontrolled distant metastasis;\n* Patients who have previously undergone radical mastectomy;\n* Patients who refused to provide postoperative follow-up information.",{"count":55,"type":22},150,[25],"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.",[28],[28,30,60,31],"Breast reconstruction","2025-11-27",{"date":63,"type":37},"2025-12-02",{"date":65,"type":22},"2025-12-01",{"date":67,"type":22},"2026-12-31",{"name":43,"class":44},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":90,"locationsCount":45},"100611226","drain-removal-on-postoperative-safety-and-patient-satisfaction-in-r-e-nsm-with-prepectoral-dibr-100611226","NCT07237828","Drain Removal on Postoperative Safety and Patient Satisfaction in R-E-NSM With Prepectoral DIBR","Drainage Removal After Reverse-Sequence Endoscopic Nipple-Sparing Mastectomy With Direct-to-Implant Prepectoral Breast Reconstruction on Postoperative Safety and Patient Satisfaction : A National Multicenter, Open, Randomized Controlled Study","DRAIN","Inclusion Criteria:\n\n* Female patients aged 18-70 years (inclusive);\n* Patients scheduled for unilateral or bilateral reverse-sequence endoscopic nipple-sparing- mastectomy with immediate prepectoral direct-to-implant breast reconstruction, with the option of concurrent contralateral endoscopic breast augmentation;\n* Patients with preoperative pathological confirmation of carcinoma in situ, invasive cancer, or those undergoing prophylactic mastectomy;\n* Patients with a maximum tumor diameter≤5 cm (before\u002Fafter neoadjuvant chemotherapy), and no clinical or radiological evidence of nipple, skin, chest wall invasion, or distant metastasis;\n* BMI \\\u003C 40 kg\u002Fm²;\n* Implant volume \\\u003C 600 mL;\n* Patients who are able and willing to sign the informed consent form.\n\nExclusion Criteria:\n\n* History of breast surgery within 1 year prior to this operation (excluding VABB and biopsy);\n* Tumor invasion of the skin, pectoralis major muscle, chest wall, or nipple-areola complex;\n* Advanced tumor stage (M1);\n* Breast cancer during pregnancy or lactation;\n* Scars below the nipple level and a history of previous radiotherapy;\n* Patients with severe comorbidities before surgery, poorly controlled diabetes, immunodeficiency, or poor general condition that cannot tolerate surgery;\n* HbA1c \\> 7.5%;\n* Active smoking history (≥20 cigarettes per day);\n* Intraoperative flap burns, intraoperative nipple excision; postoperative complications such as infection, flap ischemia, or surgical cavity bleeding within 1-4 days after surgery; or other causes leading to incisions on the surface of the breast; patients who undergo nipple excision within 1 month after surgery should be excluded from the study;\n* Currently participating in other clinical studies that may affect participation in this trial.\n* Refusal to sign the informed consent form.",{"count":78,"type":22},379,[25],"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.",[28],[28,31,83,30],"Nipple-sparing mastectomy","2025-11-14",{"date":86,"type":37},"2025-11-20",{"date":65,"type":22},{"date":89,"type":22},"2032-06-30",{"name":43,"class":44},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":99,"targetDuration":4,"studyType":23,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100592568","the-application-of-huaxi-hole-1-in-reverse-sequence-endoscopic-nipple-sparing-mastectomy-with-direct-to-implant-breast-reconstruction-100592568","NCT06995118","The Application of \"HUAXI Hole 1\" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction","The Application of \"HUAXI Hole 1\" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction: A National Multicenter, Open-Label, Randomized Controlled Trial (HUAXI-h-01)","HUAXI-h-01","Inclusion criteria:\n\n* Female patients aged 18-70 years (inclusive18 and 70 years);\n* Patients eligible for unilateral or bilateral reverse-sequence endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction, with concurrent contralateral endoscopic augmentation mammoplasty permitted;\n* Patients with preoperative pathological confirmation of non-specialized breast cancer (e.g., ductal carcinoma in situ, invasive ductal carcinoma, invasive lobular carcinoma) or eligibility for prophylactic mastectomy;\n* For non-specialized breast cancer patients, preoperative tumor size ≤5 cm (post-neoadjuvant chemotherapy if applicable), and no clinical or imaging evidence of invasion to the nipple, skin, subcutaneous fat, chest wall (referring to the bony thorax and intercostal muscles, excluding the pectoralis major and minor muscles) or distant metastasis preoperatively;\n* Patients volunteered to provide informed consent.\n\nExclusion criteria:\n\n* History of open breast surgery within 1 year before this procedure (excluding minimally invasive vacuum-assisted biopsy);\n* Breast cancer diagnosed during pregnancy or lactation;\n* Subnipple-plane scarring with radiotherapy;\n* Metastatic breast cancer (M1);\n* Severe comorbidities precluding general anesthesia or surgery;\n* BMI ≥40 kg\u002Fm²;\n* HbA1c \\>7.5%;\n* Immunodeficiency;\n* Active smoking with ≥20 cigarettes per day\n* Patients with concurrent participation in conflicting clinical trials.",{"count":100,"type":22},337,[25],"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.",[104],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[28,30,83,31],"RECRUITING","2025-06-28",{"date":109,"type":37},"2025-07-02",{"date":111,"type":37},"2025-06-17",{"date":113,"type":22},"2031-12-31",{"name":43,"class":44},20,""]