[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495008":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":36,"locations":45,"responsibleParty":61,"collaborators":63,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":11,"eligibilityCriteria":80,"healthyVolunteers":77,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":11,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"external pancreatic duct stent","EXPERIMENTAL",null,[13],"Procedure: External pancreatic duct stent",{"label":15,"type":10,"description":11,"interventionNames":16},"internal pancreatic duct stent",[17],"Procedure: Internal pancreatic duct stent",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"PROCEDURE","External pancreatic duct stent","All pancreaticoduodenectomies were performed by the same surgical team at our pancreatic center throughout the study period. According to the preoperative laboratory results, medical imaging data, and intraoperative conditions, the laparoscopic or open pancreaticoduodenectomy, or pylorus-preserving pancreaticoduodenectomy was performed at the discretion of the individual surgeon. The child's technique was implemented to achieve digestive tract reconstruction, and all patients underwent a duct-to-mucosa pancreaticojejunostomy. The external pancreatic duct stent left the other end exteriorized through the proximal jejunum via a small enterotomy that was fixed in the abdominal wall.",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Internal pancreatic duct stent","All pancreaticoduodenectomies were performed by the same surgical team at our pancreatic center throughout the study period. According to the preoperative laboratory results, medical imaging data, and intraoperative conditions, the laparoscopic or open pancreaticoduodenectomy, or pylorus-preserving pancreaticoduodenectomy was performed at the discretion of the individual surgeon. The child's technique was implemented to achieve digestive tract reconstruction, and all patients underwent a duct-to-mucosa pancreaticojejunostomy. The internal pancreatic duct stent, a silicone catheter with multiple side pores, was inserted into the main pancreatic duct and the other end was placed in the jejunum cavity.",[15],[29,33],{"name":30,"affiliation":31,"role":32},"Sheng Yan, Doctor","2nd Affiliated Hospital, School of Medicine, Zhejiang University, China","STUDY_CHAIR",{"name":34,"affiliation":31,"role":35},"Yuancong Jiang, Doctor","PRINCIPAL_INVESTIGATOR",[37,41],{"name":30,"role":38,"phone":39,"phoneExt":11,"email":40},"CONTACT","13957161680","shengyan@zju.edu.cn",{"name":42,"role":38,"phone":43,"phoneExt":11,"email":44},"Guogang Li, Doctor","13819198620","liguogangnag@163.com",[46],{"facility":31,"status":47,"city":48,"state":11,"zip":11,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Hangzhou","China","CN",{"type":52,"coordinates":53},"Point",[54,55],120.16142,30.29365,{"lat":55,"lon":54},[58],{"name":34,"role":38,"phone":59,"phoneExt":11,"email":60},"18868107327","jiangyuancong@zju.edu.cn",{"type":62,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[64,66,68,70,72],{"name":65,"class":6},"Ningbo No. 1 Hospital",{"name":67,"class":6},"Huizhou Municipal Central Hospital",{"name":69,"class":6},"Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University",{"name":71,"class":6},"The Third Affiliated Hospital of Wenzhou Medical University",{"name":73,"class":74},"Linping First People's Hospital","UNKNOWN","100495008","a-multicenter-randomized-controlled-study-of-external-pancreatic-duct-stents-in-pancreaticoduodenectomy-100495008",false,"NCT05725590","A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy","Inclusion Criteria:\n\n* Pancreatoduodenectomy with pancreaticojejunal mucosa anastomosis was performed;\n\n  * The patient has no combined organic diseases in the heart, lungs, or kidneys;\n\n    * No history of chemotherapy, radiotherapy, upper abdominal surgery, or combined with other tumors; ④ The risk score of the pancreatic fistula of the patient according to the definition of the updated Alternative Fistula Risk Score (ua-FRS). Patients with a ua-FRS score higher than 5% were included in this study.\n\nExclusion Criteria:\n\n* Previous history of other tumors or upper abdominal surgery; ② Multiple lesions and distant metastasis;\n\n  * Patients with organic diseases of important organs such as the heart, lung, and kidney, who cannot tolerate surgery, or patients who are more than 75 years old or less than 18 years old; ④ Other measures were performed to prevent pancreatic fistula, such as fibrin glue sealing, which may affect the accuracy of this study.","ALL","18 Years","75 Years",{"count":85,"type":86},300,"ESTIMATED","INTERVENTIONAL",[89],"NA","The prognostic value of external vs internal pancreatic duct stents after pancreaticoduodenectomy remains controversial. This study aimed to evaluate the benefits of external and internal stents using the Updated Alternative Fistula Risk Score in both high-risk and low-risk patients with regard to the incidence of clinically relevant postoperative pancreatic fistula.",[92],"Pancreatic Fistula",[94,21,95],"Clinically relevant postoperative pancreatic fistula","Pancreaticoduodenectomy","2023-02-02",{"date":98,"type":99},"2023-02-13","ACTUAL",{"date":96,"type":99},{"date":102,"type":86},"2026-08",{"name":5,"class":6},1]