Intraoperative Pyloric Balloon Dilatation to Reduce Delayed Gastric Emptying After PPPD

NCT07451392 | Not Yet Recruiting

• 1 other identifier: Intraoperative Pyloric Balloon
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Delayed Gastric Emptying; Postoperative Nausea and Vomiting; Gastric Emptying Time

Keywords

Delayed Gastric Emptying; Pylorus-Preserving Pancreatoduodenectomy; PPPD; Pyloric Balloon Dilatation; Early Postoperative Vomiting; Pylorospasm

Outcome Measures

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.

  Up to 7 days postoperatively

Study Arms (2)

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.

Procedure: Intraoperative Pyloric Balloon Dilatation

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.

Interventions

Intraoperative Pyloric Balloon Dilatation PROCEDURE

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.

Pyloric Dilatation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Gastroparesis; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at General Surgery Department, Assiut University

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 5, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-02