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

Phase 3

Recruiting

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

• Registration Number: NCT05551832
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-23
• Status Verified: 2022-10
• Study Start: 2022-10-10
• Last Update Submitted: 2022-10-23
• Last Update Posted: 2022-10-25
• Primary Completion: 2023-10-01
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months	Arm I (Placebo),	Placebo beginning day of hospital discharge following PPPD for 6 months
Esmesol 40mg after PPPD for 6 months	Arm II (ESMESOL)	Esmesol 40mg beginning day of hospital discharge following PPPD for 6 months

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GangnamSeverance Hospital; 🇰🇷 Seoul, Korea, Republic of