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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months | Placebo Comparator | Placebo beginning day of hospital discharge following PPPD for 6 months |
|
| Esmesol 40mg after PPPD for 6 months | Experimental | Esmesol 40mg beginning day of hospital discharge following PPPD for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm I (Placebo), | Drug | Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Marginal ulcer incidence | Number of Participants occurs Endoscopic visualization of presence or absence of marginal ulcers | Time Frame: during first 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| QOL | Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia. | Time Frame: during first 6 months after surgery |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JoonSeong Park | Contact | 82-2-2019-3375 | JSPARK330@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GangnamSeverance Hospital | Recruiting | Seoul | South Korea |
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Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
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| Arm II (ESMESOL) | Drug | SMESOL 40 mg dose administrea daily at bedtime for 6 months after PPPD , |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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