Efficacy of an Ecabet Sodium and Proton Pump Inhibitor (PPI) Combination Therapy in the Treatment of Iatrogenic Ulcer After Endoscopic Submucosal Dissection: A Prospective Randomized Controlled Trial
Phase 4
18 Years
80 Years
18 Years
80 Years
Open (Enrolling by invite only)
Both
Delayed Bleeding,, Healing Ulcer, Quality of Ulcer
Both
Delayed Bleeding,, Healing Ulcer, Quality of Ulcer
Trial Information
Efficacy of an Ecabet Sodium and Proton Pump Inhibitor (PPI) Combination Therapy in the Treatment of Iatrogenic Ulcer After Endoscopic Submucosal Dissection: A Prospective Randomized Controlled Trial
Inclusion Criteria:
- gastric adenomas or differentiated EGC (any size without ulcers or signs of
submucosal invasion; intramucosal differentiated-type EGC < 3 cm with a scar; and no
lymph node involvement or metastasis by CT)
Exclusion Criteria:
- recent use of a PPI, H2RA, bismuth, and antibiotics
- current use of aspirin, non-steroidal anti-inflammatory drugs, or corticosteroids
- Helicobacter pylori infection not evaluated appropriately by endoscopic biopsy and
serology
- a history of subtotal gastrectomy; patients who underwent surgery due to ESD
complications; known hypersensitivity to PPIs
- chronic co-morbid disease, such as chronic liver and renal disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
to determine the difference in delayed bleeding with PPI or PPI+ES
Outcome Time Frame:
the time of bleeding occured or post 4 weeks after ESD
Safety Issue:
Yes
Authority:
South Korea: Institutional Review Board
Study ID:
2010-10-044
NCT ID:
NCT01308177
Start Date:
March 2011
Completion Date:
March 2012
Related Keywords:
- Delayed Bleeding,
- Healing Ulcer
- Quality of Ulcer
- Hemorrhage
- Ulcer
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