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Trial Title:
Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study
NCT ID:
NCT05551832
Condition:
Pancretic Dissease (Benign/Malignancy)
BIle Duct Diseae(Benign/Malignancy)
Ampulla of Vater Disease (Benign/Malignancy)
Conditions: Official terms:
Neoplasms
Peptic Ulcer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Arm I (Placebo),
Description:
Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
Arm group label:
Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
Intervention type:
Drug
Intervention name:
Arm II (ESMESOL)
Description:
SMESOL 40 mg dose administrea daily at bedtime for 6 months after PPPD ,
Arm group label:
Esmesol 40mg after PPPD for 6 months
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.
Criteria for 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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
GangnamSeverance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
JoonSeong Park
Phone:
82-2-2019-3375
Email:
JSPARK330@yuhs.ac
Start date:
October 10, 2022
Completion date:
May 30, 2025
Lead sponsor:
Agency:
Gangnam Severance Hospital
Agency class:
Other
Source:
Gangnam Severance Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05551832
