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NCT05551832 | Recruiting | Pancretic Dissease (Benign/Malignancy)


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

Gangnam Severance Hospital

Information provided by (Responsible Party):

Joon Seong Park

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.

Condition or disease

Pancretic Dissease (Benign/Malignancy)

BIle Duct Diseae(Benign/Malignancy)

Ampulla of Vater Disease (Benign/Malignancy)

Intervention/treatment

Arm I (Placebo),

Arm II (ESMESOL)

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 360 participants
Masking: Quadruple
Primary Purpose: Treatment
Official Title: Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study
Actual Study Start Date : October 10, 2022
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : May 30, 2025
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),

Experimental: Esmesol 40mg after PPPD for 6 months

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

Drug: Arm II (ESMESOL)

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

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

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

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Locations


Recruiting

Korea, Republic of,

GangnamSeverance Hospital

Seoul, Korea, Republic of,

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