Intraoperative Pyloric Balloon Dilatation to Reduce Delayed Gastric Emptying After PPPD (NCT07451392) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Intraoperative Pyloric Balloon Dilatation to Reduce Delayed Gastric Emptying After PPPD
70 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.