[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650314":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":11,"centralContacts":32,"locations":38,"responsibleParty":100,"collaborators":11,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":11,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":11,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":11,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Nanfang Hospital, Southern Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Modified Single-Incision Plus One-Port Laparoscopic Pancreaticoduodenectomy","EXPERIMENTAL",null,[13],"Procedure: Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Five-Port Laparoscopic Pancreaticoduodenectomy","ACTIVE_COMPARATOR","Patients undergo conventional five-port laparoscopic pancreaticoduodenectomy. Standard laparoscopic technique with five abdominal trocars is adopted for pancreaticoduodenectomy and digestive tract reconstruction.",[19],"Procedure: Conventional Laparoscopic Pancreaticoduodenectomy",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy","A pancreaticoduodenectomy performed through a 60- to 80-mm periumbilical single-incision access platform containing three trocars, with one additional 12-mm laparoscopic port. Resection and reconstruction are performed according to the standardized multicenter operative protocol.",[9],[27],"mSILPD+1",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"Conventional Laparoscopic Pancreaticoduodenectomy","A conventional laparoscopic pancreaticoduodenectomy performed using five trocar ports, followed by resection and reconstruction according to the standardized multicenter operative protocol.",[15],[33],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Chenfenglin Yang","CONTACT","+86 18583065665","15182546920@163.com",[39,57,71,86],{"facility":40,"status":41,"city":42,"state":43,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)","RECRUITING","Chongqing","Chongqing Municipality","China","CN",{"type":47,"coordinates":48},"Point",[49,50],106.55771,29.56026,{"lat":50,"lon":49},[53],{"name":54,"role":35,"phone":55,"phoneExt":11,"email":56},"Tang","+86 13594016196","ttyichen@tmmu.edu.cn",{"facility":5,"status":41,"city":58,"state":59,"zip":60,"country":44,"countryCode":45,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Guangzhou","Guangdong","510515",{"type":47,"coordinates":62},[63,64],113.25,23.11667,{"lat":64,"lon":63},[67],{"name":68,"role":35,"phone":69,"phoneExt":11,"email":70},"Qifan Zhang","+86 13632101860","gdwkzqf@126.com",{"facility":72,"status":41,"city":73,"state":74,"zip":75,"country":44,"countryCode":45,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"West China Hospital, Sichuan University","Chengdu","Sichuan","610041",{"type":47,"coordinates":77},[78,79],104.06667,30.66667,{"lat":79,"lon":78},[82],{"name":83,"role":35,"phone":84,"phoneExt":11,"email":85},"Yunqiang Cai","+86 18980605029","yunqiangcaiwch@163.com",{"facility":87,"status":41,"city":88,"state":74,"zip":89,"country":44,"countryCode":45,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"The People's Hospital of Jianyang City","Jiancheng","641400",{"type":47,"coordinates":91},[92,93],104.54912,30.39097,{"lat":93,"lon":92},[96],{"name":97,"role":35,"phone":98,"phoneExt":11,"email":99},"Zhang","028-27237840","1181843002@qq.com",{"type":101,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100650314","modified-single-incision-plus-one-port-versus-conventional-five-port-laparoscopic-pancreaticoduodenectomy-for-nonpancreatic-periampullary-adenocarcinomas-100650314",false,"NCT07744087","Modified Single-Incision Plus One-Port Versus Conventional Five-Port Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas","Modified \"Single-Incision Plus One \"Versus Conventional \"Five-Port\" Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas: Study Protocol for A Multicentre Randomised Controlled Trial","Inclusion Criteria:\n\n* Age 18 years or older and younger than 75 years.\n* Histopathologically confirmed non-pancreatic periampullary carcinoma, or a high clinical suspicion of non-pancreatic periampullary carcinoma when preoperative pathological confirmation is unavailable.\n* Determined by preoperative multidisciplinary team evaluation to require pancreaticoduodenectomy.\n* Able to understand and comply with study procedures.\n* Able and willing to provide written informed consent before any study-specific screening procedure.\n* Expected to benefit from therapeutic pancreaticoduodenectomy according to applicable clinical guidelines.\n\nExclusion Criteria:\n\n* Distant metastasis, including peritoneal, hepatic, distant lymph node, or other organ metastasis.\n* Requirement for distal, central, or total pancreatectomy, or another palliative procedure.\n* Preoperative American Society of Anesthesiologists physical status classification of 4 or higher.\n* Concurrent malignancy other than the target cancer.\n* Pregnancy or breastfeeding.\n* Severe psychiatric disorder that would interfere with study participation.\n* Receipt of neoadjuvant chemotherapy or radiotherapy before surgery.\n* Vascular invasion requiring vascular resection, as determined by the multidisciplinary team based on preoperative abdominal imaging.\n* Body mass index greater than 35 kg\u002Fm².\n* Participation in another clinical trial within the previous 3 months.","ALL","18 Years","75 Years",{"count":113,"type":114},232,"ESTIMATED","INTERVENTIONAL",[117],"NA","This multicenter, randomized, controlled, non-inferiority trial will compare modified single-incision plus one-port laparoscopic pancreaticoduodenectomy (mSILPD+1) with conventional five-port laparoscopic pancreaticoduodenectomy (CLPD) in adults with histologically confirmed or highly suspected non-pancreatic periampullary carcinoma who are candidates for pancreaticoduodenectomy. A total of 232 participants will be randomly assigned in a 1:1 ratio. Outcome assessors who adjudicate complications and interpret imaging will be masked to treatment assignment. The primary outcomes are all-cause mortality within 90 days after surgery and overall survival at 1 year after surgery. Secondary outcomes will assess postoperative complications, surgical performance, postoperative recovery, disease-free survival, quality of life, and health-care costs.",[120,121,122],"Ampullary Carcinoma","Duodenal Adenocarcinoma","Distal Cholangiocarcinoma","2026-08-02",{"date":125,"type":126},"2026-08-04","ACTUAL",{"date":128,"type":126},"2026-06-04",{"date":130,"type":114},"2029-12",{"name":5,"class":6},4]