The multicenter randomized controlled trial on the effect of Helicobacter pylori eradication for endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing
- Conditions
- Patients have early gastric cancer endoscopic therapeutic indications lesions and adaptation expanding lesions, are Helicobacter pylori infection including the adenoma
- Registration Number
- JPRN-UMIN000015927
- Lead Sponsor
- Aichi Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 130
Not provided
Patients by narrowing and deformation of the upper gastrointestinal tract, drug administration and the endoscope insertion can be considered difficult. Patients with complications of active malignancy or other serious systemic. Patients with active ulcer. Serious complications, patients with (heart failure, renal failure than (creatinine clearance 60 (mL / min)), liver failure, respiratory failure). Patients on dialysis. Patients with a history of allergy to the study drug. Patients during pregnancy and lactation. Patients with a history of radiation therapy to the upper abdomen. Esophageal lesions, and patients who are scheduled for endoscopic therapy at the same time against duodenal lesions. Patients with registration history in this study. Patients who did not consent to participate in this clinical study. Others, patients who test responsibility (sharing) doctor has determined to be inappropriate as a subject.
Study & Design
- Study Type
- Interventional,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Artificial ulcer healing rate after ESD enforcement 56 days
- Secondary Outcome Measures
Name Time Method Reduction ratio of ESD after artificial ulcer, adverse events incidence