[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634780":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":50,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":78,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Areola Preservation & Nipple Reconstruction Group","EXPERIMENTAL","Patients with intraoperatively confirmed nipple involvement during nipple-sparing mastectomy, who receive areola-preserving surgery (pending negative second frozen section of the peri-areolar margin) combined with immediate nipple reconstruction via a local flap technique (e.g., purse-string suture), followed by immediate breast reconstruction.",[13],"Procedure: Areola-Preserving Nipple-Sparing Mastectomy with Immediate Nipple Reconstruction",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Areola-Preserving Nipple-Sparing Mastectomy with Immediate Nipple Reconstruction","This is a combined surgical procedure for patients with intraoperative nipple involvement during nipple-sparing mastectomy. After resection of the involved nipple, a full-thickness peri-areolar tissue margin is harvested for a second intraoperative frozen section. If the margin is negative for carcinoma, the areola skin is preserved. An immediate nipple reconstruction is then performed using a local skin flap technique (e.g., purse-string suture). This is followed by standard immediate breast reconstruction (implant-based or autologous).",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Ke Wang, MD","Department of Breast Surgery, The Second Affiliated Hospital of Zhejiang University School of Medicine","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Jingxin Jiang, MD","CONTACT","+86-1356711447","blwangke@126.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Bing Yang, MD","+86-18868112181","11718405@zju.edu.cn",[37],{"facility":38,"status":20,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":20},"The Second Affiliated Hospital of Zhejiang University School of Medicine","Hangzhou","Zhejiang","310009","China","CN",{"type":45,"coordinates":46},"Point",[47,48],120.16142,30.29365,{"lat":48,"lon":47},{"type":51,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100634780","areola-preservation-in-nsm-with-nipple-involvement-100634780",false,"NCT07544134","Areola Preservation in NSM With Nipple Involvement","Oncologic Safety and Aesthetic Outcomes of Areola Preservation With Simultaneous Nipple Reconstruction in Nipple-Sparing Mastectomy With Intraoperative Nipple Involvement: A Single-Center, Prospective, Exploratory Study","APRESERVE-1","Inclusion Criteria:\n\n1. Female, age ≥ 18 years.\n2. Pathologically confirmed primary invasive breast carcinoma or ductal carcinoma in situ (DCIS).\n3. Clinical tumor stage cTis-2, N0-2, M0 (AJCC 8th Edition).\n4. Planned for therapeutic nipple-sparing mastectomy (NSM) with immediate reconstruction.\n5. Intraoperative frozen section confirms involvement of the nipple core tissue by invasive carcinoma or DCIS.\n6. ECOG performance status 0-1.\n7. Willing and voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n1. Clinical or radiological suspicion of areola or skin involvement.\n2. Inflammatory breast cancer.\n3. Pregnancy or lactation.\n4. Any severe medical or psychiatric condition that, in the investigator's judgment, would preclude safe participation or compliance.\n5. Severe uncontrolled comorbidities with a life expectancy of less than 5 years.","FEMALE","18 Years",{"count":63,"type":64},40,"ESTIMATED","INTERVENTIONAL",[67],"NA","Background:\n\nDuring nipple-sparing mastectomy (a surgery that removes breast tissue but keeps the nipple and areola), doctors test the tissue behind the nipple right away. If cancer cells are found in this nipple tissue, current guidelines say the entire nipple and areola must be removed. However, research suggests that when the nipple is involved, the surrounding pigmented skin (the areola) is very rarely affected by cancer. Removing it might be unnecessary and leads to a worse cosmetic outcome, which can impact a woman's self-image and quality of life. Currently, there is no prospective study to guide whether the areola can be safely preserved in this specific situation.\n\nPurpose:\n\nThis is a pilot study that aims to explore the feasibility, safety, and early outcomes of a new surgical procedure: preserving the areola and performing immediate nipple reconstruction when cancer is found in the nipple during surgery.\n\nStudy Plan:\n\nThis is a single-arm, single-center, prospective, exploratory study. Women with early-stage breast cancer who are scheduled for a nipple-sparing mastectomy will be invited. Only if cancer is confirmed in the nipple during their surgery will they be enrolled into the single test group. In this group:\n\nThe nipple is removed.\n\nA small ring of tissue from under the areola is tested immediately (second frozen section). If this ring shows no cancer, the areola skin is preserved.\n\nA new nipple is created during the same operation using a local skin flap technique (purse-string suture).\n\nAll patients will have immediate breast reconstruction.\n\nWe plan to include about 40-60 patients at one hospital. Patients will be closely followed for 3 years with regular check-ups and scans to monitor for any cancer recurrence or complications.\n\nWhat We Will Measure (Exploratory Endpoints):\n\nSafety \\& Feasibility: The success rate of areola preservation (based on negative second frozen section), surgical complication rates (e.g., infection, tissue necrosis).\n\nEarly Effectiveness: The rate of cancer returning in the breast\u002Fchest wall area within 3 years (local recurrence).\n\nPatient-Reported Outcomes: Patient satisfaction with their breasts and well-being, measured by the BREAST-Q questionnaire before and after surgery.\n\nWhy This Study is Important:\n\nThis is the first prospective study to systematically evaluate this new surgical approach. The results will provide crucial preliminary data on safety and early outcomes. If the findings are promising, they will form the foundation for designing a larger, controlled trial in the future. Ultimately, this research could lead to a new option that offers women better cosmetic results and improved quality of life after mastectomy.",[70,71,72],"Breast Cancer","Ductal Carcinoma In Situ, DCIS","Invasive Breast Carcinoma",[70,74,75,76,77],"Nipple Sparing Mastectomy","NSM","Nipple Areola Complex","Nipple Reconstruction","NOT_YET_RECRUITING","2026-04-19",{"date":81,"type":82},"2026-04-22","ACTUAL",{"date":84,"type":64},"2026-05-01",{"date":86,"type":64},"2030-01-15",{"name":5,"class":6},1]