Clinical Trial

Intraoperative Pyloric Balloon Dilatation to Reduce Delayed Gastric Emptying After PPPD

Not Yet Recruiting
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Summary
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. Participants 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.
Trial Details
NCT Number NCT07451392
Lead Sponsor Assiut University
Conditions Delayed Gastric Emptying, Postoperative Nausea and Vomiting, Gastric Emptying Time
Enrollment 70 participants
Start Date 2026-04
Primary Completion 2027-04 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-03-05