on-inferiority study of P-CAB for Cure of Ulcer Resected by ESD
Not Applicable
- Conditions
- early gastric cancer or gastric adenoma
- Registration Number
- JPRN-UMIN000031564
- Lead Sponsor
- Keio University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with past history of surgery for upper GI tract. 2) Patients with eGFR<30 or on hemodialysis. 3) Patients with uncompensated liver cirrhosis. 4) Patients with severe bleeding tendency. 5) Patients taking systemic NSAIDs or steroid. 6) Patients taking anti-platelet or coagulant drugs. 7) Patients taking PPI or P-CAB continuously at the time of registry. 8) Patients with perforation during ESD. 9) Patients not fulfilling curative criteria by ESD. 10) Patients taking Atazanavir or Rirupibirin. 11) Patients who attending physicians consider to be inappropriate due to other reasons mentioned above
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of complete closure of post ESD ulcer at 24 weeks after gastric ESD.
- Secondary Outcome Measures
Name Time Method 1) Proportion of bleeding within 3 weeks after gastric ESD. 2) Proportion of bleeding more than 3 weeks after gastric ESD. 3) Proportion of perforation within 3 weeks after gastric ESD. 4) Proportion of perforation more than 3 weeks after gastric ESD. 5) Proportion of complete closure of post ESD ulcer at 8 weeks after gastric ESD. 6) Status of post ESD ulcer (evaluated based on Sakita Miwa classification) at 8 and 24 weeks after ESD. 7) Medical care cost.