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

Primary Purpose

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

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Arm I (Placebo),
Arm II (ESMESOL)
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancretic Dissease (Benign/Malignancy)

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GangnamSeverance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months

Esmesol 40mg after PPPD for 6 months

Arm Description

Placebo beginning day of hospital discharge following PPPD for 6 months

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

Outcomes

Primary Outcome Measures

Marginal ulcer incidence
Number of Participants occurs Endoscopic visualization of presence or absence of marginal ulcers

Secondary Outcome Measures

QOL
Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.

Full Information

First Posted
September 20, 2022
Last Updated
October 23, 2022
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05551832
Brief Title
Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study
Official Title
Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancretic Dissease (Benign/Malignancy), BIle Duct Diseae(Benign/Malignancy), Ampulla of Vater Disease (Benign/Malignancy)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
Arm Type
Placebo Comparator
Arm Description
Placebo beginning day of hospital discharge following PPPD for 6 months
Arm Title
Esmesol 40mg after PPPD for 6 months
Arm Type
Experimental
Arm Description
Esmesol 40mg beginning day of hospital discharge following PPPD for 6 months
Intervention Type
Drug
Intervention Name(s)
Arm I (Placebo),
Intervention Description
Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
Intervention Type
Drug
Intervention Name(s)
Arm II (ESMESOL)
Intervention Description
SMESOL 40 mg dose administrea daily at bedtime for 6 months after PPPD ,
Primary Outcome Measure Information:
Title
Marginal ulcer incidence
Description
Number of Participants occurs Endoscopic visualization of presence or absence of marginal ulcers
Time Frame
Time Frame: during first 6 months after surgery
Secondary Outcome Measure Information:
Title
QOL
Description
Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.
Time Frame
Time Frame: during first 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JoonSeong Park
Phone
82-2-2019-3375
Email
JSPARK330@yuhs.ac
Facility Information:
Facility Name
GangnamSeverance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JoonSeong Park
Phone
82-2-2019-3375
Email
JSPARK330@yuhs.ac

12. IPD Sharing Statement

Learn more about this trial

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

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