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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancretic Dissease (Benign/Malignancy); BIle Duct Diseae(Benign/Malignancy); Ampulla of Vater Disease (Benign/Malignancy)
• Intervention / Treatment: Drug: Arm I (Placebo),; Drug: Arm II (ESMESOL)

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: JoonSeong Park; Phone Number: 82-2-2019-3375; Email: JSPARK330@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • GangnamSeverance Hospital
    • Contact: JoonSeong Park; Phone Number: 82-2-2019-3375; Email: JSPARK330@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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),; Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
Experimental: Esmesol 40mg after PPPD for 6 months; Esmesol 40mg beginning day of hospital discharge following PPPD for 6 months	Drug: Arm II (ESMESOL); SMESOL 40 mg dose administrea daily at bedtime for 6 months after PPPD ,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal ulcer incidence	Number of Participants occurs Endoscopic visualization of presence or absence of marginal ulcers	Time Frame: during first 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QOL	Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.	Time Frame: during first 6 months after surgery

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): May 30, 2025

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 23, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Neoplasms; Peptic Ulcer
• Other Study ID Numbers: 3-2022-0193

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No