Comparative study of efficacy of rabeprazole and lansoprazole for endoscopic submucosal dissection-induced ulcer
- Conditions
- Neoplasms
- Registration Number
- KCT0008599
- Lead Sponsor
- Kangwon National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
(1) A person who is 19 years of age or older as the date of obtaining written consent
(2) Among patients diagnosed with early gastric cancer and gastric adenoma and to undergo endoscopic submucosal dissection, endoscopic submucosal dissection was performed for differentiated early cancer of less than 2 cm without ulcer localized in the mucous membrane, adenoma and dysplasia greater than 1.5 cm, It targets adenomas accompanied by fibrosis.
(3) A person who voluntarily decided to participate and gave written consent to the consent form for clinical trial subjects
(1) Those who cannot complete the questionnaire by themselves
(2) Those with a history of hypersensitivity to PPI-type ingredients or benzimidazoles
(3) Those who are taking drugs such as warfarin, phenytoin, theophylline, diazepam, etc.
(4) Patients who have taken PPI, histamine 2 receptor antagonist (H2RA), or potassium-competitive acid blockers (P-CAB) drugs within 4 weeks of performing endoscopic mucosal resection ruler
(5) Those with clinically significant disorders in the liver, kidneys, cardiovascular system, respiratory system, endocrine system, and central nervous system
(6) Those who showed the following abnormal values in blood chemistry tests within 4 weeks of endoscopic mucosal resection
- BUN, creatinine > 2 times the organ upper limit of normal
- AST, ALT, ALP, total bilirubin > 2 times the upper limit of normal
(7) Pregnant and lactating women or those who intend to become pregnant
(8) Patients with a history of alcohol abuse. Those who are judged difficult to participate in research due to bipolar disorder, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychiatric disorders
(9) Those who cannot undergo upper gastrointestinal endoscopy (esophageal disease, gastrointestinal bleeding, etc.)
(10) Those for whom endoscopic submucosal resection is contraindicated (thrombocytopenia, coagulopathy, etc.)
(11) Those who have undergone surgery that may affect gastric acid secretion
(12) Those who have taken contraindications to use in combination with the approval of investigational drugs (atazanavir, nelfinavir, or rilpivirine-containing agents, etc.), antiplatelet agents, and anticoagulants within 1 week of endoscopic mucosal resection
(13) A person who has not obtained the informed consent of the subject and guardian
(14) In addition to the above, those who have clinically significant findings that are considered inappropriate for this test based on medical judgment by the tester
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the area of iatrogenic gastric ulcers after ESD
- Secondary Outcome Measures
Name Time Method delayed bleeding;scar formation rate;Resolving iatrogenic gastric ulcer-related symptoms after ESD