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

NCT05551832 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2022-10-25

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Arm I (Placebo),

Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months

DRUG

Arm II (ESMESOL)

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

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2023-10-01
Completion
2025-05-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05551832 on ClinicalTrials.gov