Efficacy of Ecabet Sodium and Proton Pump Inhibitor Combination Therapy in the Treatment of Iatrogenic Ulcer After Endoscopic Submucosal Dissection

Study Overview
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Brief Summary
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Endoscopic submucosal dissection (ESD) is widely indicated to treat gastric adenomas and early gastric cancer (EGC).ESD is able to obtain en bloc resection of larger specimens. However, ESD has more frequent complications (delayed bleeding, ulcer healing, ulcer pain, and etc) due to a more complex procedure. To prevent delayed bleeding, to induce rapid ulcer healing, and to control the ulcer pain acid-suppressing agents (PPI, H2RA) are generally administered. although PPIs are widely indicated as first-line drugs for peptic ulcers, PPI drugs are not fully superior to H2RAs or other combination drugs for treatment of iatrogenic ulcer healing and delayed bleeding. Ecabet sodium (ES)is a widely used mucoprotective agent for the treatment of gastric ulcers. Recently, one study showed the additional benefits of using ES in combination with the PPI after ESD. however, this study did not show the difference of delayed bleeding and the benefit of ulcer pain control. thus, our study prospectively evaluated the difference of delayed bleeding and the benefit of ulcer pain control after ESD.

Official Title
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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

Conditions
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Delayed Bleeding,, Healing Ulcer, Quality of Ulcer

Intervention / Treatment
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* Drug: Ecabet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PPI+placebo<br> | Drug: Ecabet<br>* comparison between PPI+ ES (lanston 30mg bid+ ES 1g/1.5g/pkg bid) and PPI+placebo (lanston 30mg bid)for 28 days<br>|
| Active Comparator: PPI+ES<br> | Drug: Ecabet<br>* comparison between PPI+ ES (lanston 30mg bid+ ES 1g/1.5g/pkg bid) and PPI+placebo (lanston 30mg bid)for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine the difference in delayed bleeding with PPI or PPI+ES |  | the time of bleeding occured or post 4 weeks after ESD |