Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection?
- Registration Number
- NCT01167101
- Lead Sponsor
- Kangdong Sacred Heart Hospital
- Brief Summary
Treatment strategy of post endoscopic submucosal dissection (ESD) ulcer is not yet conclusive. Rebamipide is a mucosal protective agent widely used in East Asia and has good effect on quality of ulcer healing (QOUH). The investigators will conduct this randomized controlled study to assess the effect of a combination therapy of rebamipide and proton pump inhibitor (PPI) on post ESD ulcer healing.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 290
Inclusion Criteria
- patients underwent ESD for gastric adenoma or cancer
Exclusion Criteria
- subjects with previous gastric surgery
- subjects taking aspirin, anticoagulant, or antiplatelet agent
- subjects having malignancy except gastric cancer
- pregnant or breast-feeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pantoprazole pantoprazole controls Pantoprazole 40mg qd for 28days Pantoprazole + Rebamipde Rebamipide Pantoprazole 40mg qd + Rebamipide 100mg Tid for 28days Pantoprazole + Rebamipde pantoprazole Pantoprazole 40mg qd + Rebamipide 100mg Tid for 28days
- Primary Outcome Measures
Name Time Method Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer at 2month after endoscopic submucosal dissection (ESD) Healing efficacy will be assessed by the change of ulcer size. Quality of Ulcer Healing(QOUH) wil be assessed by nodularity in the healed ulcer by two endoscopist.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of