Clinical trial · Interventional
Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study
NCT05551832CI-TRIAL-00061650unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampulla of Vater Disease (Benign/Malignancy) | — | UNRESOLVED | — |
| BIle Duct Diseae(Benign/Malignancy) | — | UNRESOLVED | — |
| Pancretic Dissease (Benign/Malignancy) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm II (ESMESOL) | Drug | — | UNRESOLVED |
| Arm I (Placebo), | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
- description
- Placebo beginning day of hospital discharge following PPPD for 6 months
- interventionNames
- Drug: Arm I (Placebo),
- type
- EXPERIMENTAL
- label
- Esmesol 40mg after PPPD for 6 months
- description
- Esmesol 40mg beginning day of hospital discharge following PPPD for 6 months
- interventionNames
- Drug: Arm II (ESMESOL)
Primary outcomes (1)
- measure
- Marginal ulcer incidence
- timeFrame
- Time Frame: during first 6 months after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.