[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656340":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":27,"interventions":39,"overallOfficials":17,"centralContacts":45,"locations":51,"responsibleParty":70,"collaborators":17,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":17,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":17,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":17,"overallStatus":94,"whyStopped":17,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Wuhan Children's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of Severe Complications Within 30 Days Postoperatively","Incidence of Clavien-Dindo grade ≥III complications within 30 days after robot-assisted Roux-en-Y hepaticojejunostomy, including bile leakage, pancreatic leakage, intra-abdominal hemorrhage, intra-abdominal infection, wound infection, anastomotic stenosis, reoperation, and mortality.","30 days after surgery",{"measure":14,"description":15,"timeFrame":16},"Incidence of Severe Complications Within 90 Days Postoperatively","Incidence of Clavien-Dindo grade ≥III complications within 90 days after robot-assisted Roux-en-Y hepaticojejunostomy.","Postoperative 90 days",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":23,"maskingDescription":24,"whoMasked":25},"SINGLE","Arm 1: Experimental Group (Selective Drainage Group) Arm Title (Group Name): Selective Peritoneal Drainage Group or Experimental: Selective Drainage Group\n\nArm Type (Group Type): Typically selected as Experimental (Experimental)\n\nDescription (Description): Based on preoperative predictive models (cyst diameter, BMI, HGB, GLB, etc.), risk probability is calculated, and abdominal drainage tubes are placed only in high-risk children, while low-risk children do not receive drainage tubes.\n\nArm 2: Control Group (Conventional Drainage Group) Arm Title: Conventional Peritoneal Drainage Group or Active Comparator: Conventional Drainage Group\n\nArm Type: Select Active Comparator (Active Control) or No Intervention (No Intervention? But here there is conventional drainage, so Active Comparator should be selected)\n\nDescription: All children receive conventional abdominal drainage tubes postoperatively.",[26],"OUTCOMES_ASSESSOR",[28,34],{"label":29,"type":30,"description":31,"interventionNames":32},"Selective Drainage Group","EXPERIMENTAL","Patients with low-risk prediction (\\\u003C85%) do not receive abdominal drainage; patients with high-risk prediction (≥85%) receive drainage tube placement.",[33],"Procedure: Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management",{"label":35,"type":36,"description":37,"interventionNames":38},"Conventional Drainage Group","ACTIVE_COMPARATOR","All patients receive routine abdominal drainage tube placement postoperatively.",[33],[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":17},"PROCEDURE","Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management","All enrolled children undergo Da Vinci robot-assisted Roux-en-Y hepaticojejunostomy. The intervention differentiates in postoperative drainage management: the Selective Drainage Group receives abdominal drainage only when preoperative risk probability is ≥85%, while the Conventional Drainage Group receives routine drainage for all patients.",[35,29],[46],{"name":47,"role":48,"phone":49,"phoneExt":17,"email":50},"Xueqiang Yan, Doctor","CONTACT","+8615871716704","yanxueqiang1@163.com",[52],{"facility":53,"status":17,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Wuhan Children'c Hospital","Wuhan","Hubei","430016","China","CN",{"type":60,"coordinates":61},"Point",[62,63],114.26667,30.58333,{"lat":63,"lon":62},[66],{"name":67,"role":48,"phone":68,"phoneExt":17,"email":69},"Hao Zheng","+8602782438516","wch_irb@126.com",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"SPONSOR_INVESTIGATOR","Xueqiang Yan","Principal Investigator","100656340","individualized-drainage-strategy-based-on-risk-stratification-in-children-undergoing-surgery-for-choledochal-cyst-a-prospective-randomized-controlled-trial-100656340",false,"NCT07825935","Individualized Drainage Strategy Based on Risk Stratification in Children Undergoing Surgery for Choledochal Cyst: A Prospective Randomized Controlled Trial","Application of Risk-Stratified Individualized Drainage Strategy in Children With Choledochal Cyst Undergoing Robot-Assisted Roux-en-Y Hepaticojejunostomy: A Prospective Randomized Controlled Trial","Inclusion Criteria: Age 0-18 years, with clinical and imaging diagnosis of choledochal cyst (Todani type I or IV)；Scheduled to undergo Da Vinci robot-assisted Roux-en-Y hepaticojejunostomy；Complete preoperative data available: cyst diameter, BMI, hemoglobin (HGB), globulin (GLB)；Preoperative predictive model applicable for risk probability calculation；Guardian provides signed informed consent Exclusion Criteria: Complex congenital biliary malformations or other severe congenital anomalies; Previous abdominal surgery history; Pre-existing severe coagulation disorders or active infection; Severe cardiac, pulmonary, hepatic, or renal insufficiency (ASA grade ≥IV); Cyst malignancy or suspected malignancy; Emergency surgery (e.g., cyst perforation, acute suppurative cholangitis); Guardian refuses participation or unable to comply with follow-up","ALL","1 Month","18 Years",{"count":85,"type":86},80,"ESTIMATED","INTERVENTIONAL",[89],"NA","Choledochal cyst is a common congenital biliary malformation in children requiring cyst excision with Roux-en-Y hepaticojejunostomy. Traditional practice routinely places abdominal drainage tubes postoperatively. With the improved precision of robot-assisted surgery, the necessity of routine drainage has been questioned. This prospective randomized controlled trial aims to evaluate whether a selective drainage strategy based on a preoperative predictive model (using cyst diameter, age, BMI, hemoglobin, and globulin) is safe and effective compared with conventional routine drainage in children undergoing robot-assisted Roux-en-Y hepaticojejunostomy. The primary outcome is the incidence of Clavien-Dindo grade ≥III complications within 30 days postoperatively.",[92,93],"Children Following Robot-assisted Roux-en-Y Hepaticojejunostomy for Choledochal Cysts","Choledochal Cyst","NOT_YET_RECRUITING","2026-09-12",{"date":97,"type":98},"2026-09-17","ACTUAL",{"date":100,"type":86},"2026-09-01",{"date":102,"type":86},"2028-02-28",{"name":72,"class":6},1]