Investigating the prevention of marginal ulcers after pancreatic surgery using Esmesol
Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study
This study tests if a medication called Esmesol can help prevent stomach ulcers in patients who are having surgery for pancreatic or bile duct problems.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05551832 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Esmesol, a proton pump inhibitor, compared to a placebo in preventing marginal ulcers in patients undergoing pancreaticoduodenectomy (PPPD). The study is a prospective multicenter trial conducted in Korea, focusing on patients with pancreatic, bile duct, or ampulla of Vater diseases. Participants will be randomly assigned to receive either Esmesol or a placebo, and their outcomes will be monitored to determine the incidence of marginal ulcers post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older who are scheduled for pancreaticoduodenectomy and meet specific eligibility criteria.
Not a fit: Patients with a history of certain gastrointestinal diseases, previous gastric surgery, or those allergic to Esmesol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the occurrence of marginal ulcers in patients after pancreatic surgery, improving recovery and quality of life.
How similar studies have performed: While there have been studies on the use of proton pump inhibitors in various contexts, this specific approach to preventing marginal ulcers post-PPPD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- GangnamSeverance Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: JoonSeong Park
- Email: JSPARK330@yuhs.ac
- Phone: 82-2-2019-3375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.