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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-10

Study Completion Date

2025-05-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months

Placebo beginning day of hospital discharge following PPPD for 6 months

Group Type PLACEBO_COMPARATOR

Arm I (Placebo),

Intervention Type DRUG

Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months

Esmesol 40mg after PPPD for 6 months

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

Group Type EXPERIMENTAL

Arm II (ESMESOL)

Intervention Type DRUG

SMESOL 40 mg dose administrea daily at bedtime for 6 months after PPPD ,

Interventions

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Arm I (Placebo),

Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months

Intervention Type DRUG

Arm II (ESMESOL)

SMESOL 40 mg dose administrea daily at bedtime for 6 months after PPPD ,

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No