Intraoperative Pyloric Balloon Dilatation to Reduce Delayed Gastric Emptying After PPPD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥18 years) scheduled for elective PPPD due to tumors of the pancreatic head, distal bile duct, or ampulla of Vater.
Patients with no prior history of gastric surgery or severe gastroparesis.
Patients with no contraindications to balloon dilatation or intraoperative endoscopic procedures
Disqualifiers
Patients with prior gastric surgery, pyloric stenosis, or history of severe gastroparesis.
Patients with severe comorbidities that may preclude safe surgery (ASA class IV or higher).
Patients who require emergency surgery or have unresectable disease.
Patients with active gastrointestinal bleeding or severe malnutrition
Trial design
Design model
Parallel
Treatments tested in this trial
Intraoperative Pyloric Balloon Dilatation
Procedure/SurgeryA 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Pyloric DilatationExperimental treatment 1 intervention
Group B: No Pyloric DilatationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Incidence of Delayed Gastric Emptying (DGE)
The occurrence of delayed gastric emptying will be evaluated and defined according to the International Study Group of Pancreatic Surgery (ISGPS) criteria (specifically grades B or C), which are based on the severity and duration of nasogastric tube use and the patient's inability to tolerate oral intake.
Time frame
Up to 7 days postoperativelyLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: