Ampulla of Vater Disease (Benign/Malignancy), BIle Duct Diseae(Benign/Malignancy), Pancretic Dissease (Benign/Malignancy)
Conditions
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.
Interventions
DRUGArm I (Placebo),
Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
DRUGArm II (ESMESOL)
SMESOL 40 mg dose administrea daily at bedtime for 6 months after PPPD ,
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| QOL | Time Frame: during first 6 months after surgery | Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia. |
Countries
South Korea
Contacts
Primary ContactJoonSeong Park
Outcome results
None listed