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Intraoperative Pyloric Balloon Dilatation to Reduce Delayed Gastric Emptying After PPPD
Sponsor: Assiut University
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.
Official title: Intraoperative Pyloric Balloon Dilatation to Decrease Post PPPD Delayed Gastric Emptying. Does It Help? RCT Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-04
Completion Date
2027-05
Last Updated
2026-03-05
Healthy Volunteers
No
Interventions
Intraoperative Pyloric Balloon Dilatation
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.