Comparison of Helicobacter pylori Eradication plus Rebamipide combination therapy with proton pump inhibitor(PPI) alone in the treatment of endoscopic submucosal dissection(ESD) induced ulcers in H.pylori positive eary gastric cancer: Prospective Randomized Pilot Syudy
- Conditions
- H.pylori positive eary gastric cancer
- Registration Number
- JPRN-UMIN000003181
- Lead Sponsor
- Osaka Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Not provided
1)The patient with past H.pylori eradication treatment 2)The patient who coexists for active gastroduodenal ulcer 3)Upper gastrointestinal tract ablative operation and the patient with medical history of vagotomy 4)The patient who does not become a subject of medical treatment for perforation/pyloric stenosis, a massive bleeding case. 5)The patient who could not interrupt the antiplatelet agent or anticoagulant temporarily for ESD therapy. 6)The patient with medical history of shock by amoxicillin. 7)The patient with glandular infection. 8)The patient with anaphylactic medical history for penicillin antimicrobial agent, clarithromycin, a proton pump inhibitor and rebamipide. 9)The patient who is administrated drug considered to be contraindication of clarithromycin(terfenadine, cisapride, pimoside). 10)The patient with grave complication(respiratory tract disease, kidney disease, treatment by use of insulin or diabetes mellitus inadequate control) and a hindrance for examination enforcement. 11)Inadequate to entry judged by investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endoscopic evaluations:The primary endopoint is the ulcer healing(S1, S2) at 8 weeks after ESD.
- Secondary Outcome Measures
Name Time Method Endoscopic evaluations:ulcer healing rate Symptom Incidence of asynchronous multiple cancer Safety