Gangnam Severance Hospital
Joon Seong Park
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.
Pancretic Dissease (Benign/Malignancy)
BIle Duct Diseae(Benign/Malignancy)
Ampulla of Vater Disease (Benign/Malignancy)
Arm I (Placebo),
Arm II (ESMESOL)
Phase 3
Study Type : | Interventional |
Estimated Enrollment : | 360 participants |
Masking: | Quadruple |
Primary Purpose: | Treatment |
Official Title: | Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study |
Actual Study Start Date : | October 10, 2022 |
Estimated Primary Completion Date : | October 1, 2023 |
Estimated Study Completion Date : | May 30, 2025 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months Placebo beginning day of hospital discharge following PPPD for 6 months |
Drug: Arm I (Placebo), |
Experimental: Esmesol 40mg after PPPD for 6 months Esmesol 40mg beginning day of hospital discharge following PPPD for 6 months |
Drug: Arm II (ESMESOL) |
Ages Eligible for Study: | 19 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
GangnamSeverance Hospital
Seoul, Korea, Republic of,