Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: … (NCT05551832) | Clinical Trial Compass
UnknownPhase 3
Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study
South Korea360 participantsStarted 2022-10-10
Plain-language summary
This research is to determine which medication, Esmesol (PPI) or Placebo works best at reducing the chance that a patient will get an marginal ulcer after pancreaticoduodenectomy.
Who can participate
Age range
19 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:
* Subject is age ≥ 19 years Patient meets the criteria for Open/MIS PPPD Females only: Patient is willing to take a urine pregnancy test
Exclusion Criteria:
\- Subject allergic to ESMESOL Patient receiving antifungal (i.e. ketoconazole or itraconazole) Hepatic insufficiency History of Crohns disease History of Zollinger-Ellison disease Patient received an investigational drug within 30 days of enrollment Previous Gastric Surgery HX
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.
1Since this trial is specifically studying whether proton pump inhibitors (PPIs) can prevent marginal ulcers after a pylorus-preserving pancreaticoduodenectomy (PPPD), is my condition — whether it's a pancreatic, bile duct, or ampulla of Vater problem — the kind that would even make me a candidate for this type of surgery in the first place?
2Marginal ulcers can develop at the surgical connection site after PPPD — how serious a complication is that, and how would doctors monitor me for it if I were to have this surgery regardless of whether I'm in this trial?
3This is a Phase 3 study, which usually means the treatment being tested — in this case PPIs after surgery — has already shown some earlier safety signals, but the recruitment status is listed as unknown, so can you find out if this trial is still actively enrolling patients at a center near me?
4If I'm already having or planning a PPPD, is taking a PPI afterward something my surgical team would consider as standard care, and what would be different about being in this study versus just receiving that treatment as part of my normal recovery?
5Since this trial is being conducted across multiple centers in Korea, is participation realistic for my situation, and if not, is there comparable research or standard practice here that addresses the same question of preventing marginal ulcers after this type of surgery?
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.
What they're measuring
1
Marginal ulcer incidence
Timeframe: Time Frame: during first 6 months after surgery