Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study

Yonsei University Health System (YUHS)

Status and phase: Enrolling; Phase 3

Conditions: Ampulla of Vater Disease (Benign/Malignancy); BIle Duct Diseae(Benign/Malignancy); Pancretic Dissease (Benign/Malignancy)

Treatments: Drug: Arm I (Placebo),; Drug: Arm II (ESMESOL)

Study type: Interventional

Funder types: Other

Identifiers

NCT05551832

3-2022-0193

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 2 patient groups, including a placebo group

Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months

Placebo Comparator group

Description:

Placebo beginning day of hospital discharge following PPPD for 6 months

Treatment:

Drug: Arm I (Placebo),

Esmesol 40mg after PPPD for 6 months

Experimental group

Description:

Esmesol 40mg beginning day of hospital discharge following PPPD for 6 months

Treatment:

Drug: Arm II (ESMESOL)