[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627650":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":18,"responsibleParty":24,"collaborators":18,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":18,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":18,"enrollmentInfo":37,"targetDuration":18,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":48,"overallStatus":54,"whyStopped":18,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":18},{"fullName":5,"class":6},"Assiut University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pyloric Dilatation","EXPERIMENTAL","A sterile, calibrated pneumatic balloon dilator will be positioned across the pylorus under direct vision. The balloon will be inflated to a predetermined diameter (typically 18-20mm) for 1-2 minutes, repeated once if necessary, to achieve gentle mechanical stretching of the pylorus. The procedure will be performed after completion of the pancreatoduodenectomy and before gastrointestinal reconstruction.",[13],"Procedure: Intraoperative Pyloric Balloon Dilatation",{"label":15,"type":16,"description":17,"interventionNames":18},"No Pyloric Dilatation","NO_INTERVENTION","No additional intervention will be performed at the pylorus. The standard PPPD procedure will be completed without balloon dilatation or any other pyloric manipulation.",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":18},"PROCEDURE","Intraoperative Pyloric Balloon Dilatation",[9],{"type":25,"investigatorFullName":26,"investigatorTitle":27,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Taha Hussein Taha Hussein Khalil","Resident at General Surgery Department, Assiut University","100627650","intraoperative-pyloric-balloon-dilatation-to-reduce-delayed-gastric-emptying-after-pppd-100627650",false,"NCT07451392","Intraoperative Pyloric Balloon Dilatation to Reduce Delayed Gastric Emptying After PPPD","Intraoperative Pyloric Balloon Dilatation to Decrease Post PPPD Delayed Gastric Emptying. Does It Help? RCT Study","Inclusion Criteria:\n\n* Adult patients (≥18 years) scheduled for elective PPPD due to tumors of the pancreatic head, distal bile duct, or ampulla of Vater.\n* Patients with no prior history of gastric surgery or severe gastroparesis.\n* Patients with no contraindications to balloon dilatation or intraoperative endoscopic procedures\n\nExclusion Criteria:\n\n* Patients with prior gastric surgery, pyloric stenosis, or history of severe gastroparesis.\n* Patients with severe comorbidities that may preclude safe surgery (ASA class IV or higher).\n* Patients who require emergency surgery or have unresectable disease.\n* Patients with active gastrointestinal bleeding or severe malnutrition","ALL","18 Years",{"count":38,"type":39},70,"ESTIMATED","INTERVENTIONAL",[42],"NA","Pylorus-preserving pancreatoduodenectomy (PPPD) is a standard surgical treatment for tumors of the pancreatic head and surrounding areas. However, it is frequently associated with delayed gastric emptying (DGE), a complication that can lead to nausea, vomiting, and prolonged hospital stays. This study is a randomized controlled trial designed to evaluate if a simple intraoperative maneuver (pneumatic balloon dilatation of the pylorus) can reduce the incidence of early postoperative vomiting and DGE.\n\nParticipants will be randomly assigned to either the intervention group, receiving pyloric dilatation during surgery, or the control group, receiving standard surgery without dilatation. Researchers will monitor postoperative symptoms, gastric emptying function, and overall recovery to determine if this maneuver effectively improves patient outcomes.",[45,46,47],"Delayed Gastric Emptying","Postoperative Nausea and Vomiting","Gastric Emptying Time",[45,49,50,51,52,53],"Pylorus-Preserving Pancreatoduodenectomy","PPPD","Pyloric Balloon Dilatation","Early Postoperative Vomiting","Pylorospasm","NOT_YET_RECRUITING","2026-02-28",{"date":57,"type":58},"2026-03-05","ACTUAL",{"date":60,"type":39},"2026-04",{"date":62,"type":39},"2027-05",{"name":5,"class":6}]