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

Samsung Medical Center

Status and phase: Unknown; Phase 4

Conditions: Quality of Ulcer; Healing Ulcer; Delayed Bleeding,

Treatments: Drug: Ecabet

Study type: Interventional

Funder types: Other

Identifiers

NCT01308177

2010-10-044

Details and patient eligibility

About

• 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

PPI+placebo

Placebo Comparator group

Treatment:

Drug: Ecabet

PPI+ES

Active Comparator group

Treatment:

Drug: Ecabet