None listed
Conditions
Interventions
Drug : All subjects will receive proton pump inhibitor esomerazole intravenous (IV) 40 mg twice daily for the first 2 days after endoscopic mucosal stripping. Patients who do not have acute procedural
Sponsors
Yonsei University Yongin Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Men or women between the ages of 19 and 80. ?Patients undergoing endoscopic submucosal dissection for gastric adenoma or early gastric cancer who meet the following criteria: A. Differentiated early gastric cancer confined to the mucosa without ulceration B. Differentiated early gastric cancer confined to the mucosa with ulceration, less than 3 cm in size C. Differentiated early gastric cancer confined to the submucosa (<500 um), less than 3 cm in size, without ulceration D. Undifferentiated early gastric cancer confined to the mucosa, less than 2 cm in size, without ulceration ?Patients who agree to participate in this study and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: ? Hypersensitivity or history of hypersensitivity to any component of the investigational drug or to benzimidazoles. ? Patients taking or planning to take drugs related to the treatment of gastroesophageal reflux disease (P-cab, PPI, H2 receptor antagonists, prostaglandins, gastric mucosal protective agents, gastrointestinal motility promoters) within the last 2 weeks. ? Patients with any of the following abnormal laboratory tests A. Total Bilirubin, Creatinine > 1.5 times the upper limit of institutional normality B. AST, ALT, Alkaline phosphatase, BUN > 2 times the upper limit of institutional normality ? History of diagnosis of cancer other than gastric cancer within 5 years ? Underlying gastrointestinal or systemic conditions that could alter gastric physiology or study drug absorption, including Zollinger–Ellison syndrome, Barrett’s esophagus, esophageal motility disorders, esophageal stricture, pancreatitis, malabsorption disorders, or severe cardiopulmonary disease ? Prior major gastrointestinal surgery affecting acid secretion ? Inability to discontinue medications known to influence bleeding or gastric mucosal healing (warfarin, clopidogrel, direct oral anticoagulants, steroids, NSAIDs, anticholinergics, prostaglandin analogues, sucralfate, or aspirin) for the 8-week study duration ? Significant hepatic or renal dysfunction ? Pregnancy or breastfeeding ? Patients deemed unsuitable for participation in this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shrinkage ratio of ulcers identified by upper gastrointestinal endoscopy after treatment with study drug (fexuprazan) versus control drug (esomeprazole) ;Percentage of scar stage of ulcer confirmed by upper gastrointestinal endoscopy after treatment with study drug (fexuprazan) versus control drug (esomeprazole) | — |
Secondary
| Measure | Time frame |
|---|---|
| Shrinkage ratio of ulcers identified by upper gastrointestinal endoscopy after treatment with study drug (fexuprazan) versus control drug (esomeprazole);Percentage of scar stage of ulcer confirmed by upper gastrointestinal endoscopy after treatment with study drug (fexuprazan) versus control drug (esomeprazole) ;Percentageof delayed bleeding between the study drug (fexuprazan) versus control drug (esomeprazole) | — |
Countries
Korea, Republic of
Contacts
Public ContactCheal Wung Huh
Yonsei University Yongin Severance Hospital
Outcome results
None listed