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

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

Sponsors

Lead Sponsor: Samsung Medical Center

Source Samsung Medical Center
Brief Summary

- 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.

Overall Status Unknown status
Start Date March 2011
Completion Date March 2012
Primary Completion Date March 2012
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure 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
Enrollment 90
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ecabet

Description: comparison between PPI+ ES (lanston 30mg bid+ ES 1g/1.5g/pkg bid) and PPI+placebo (lanston 30mg bid)for 28 days

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Location
Facility: Samsung Medical Center
Location Countries

Korea, Republic of

Verification Date

March 2011

Responsible Party

Name Title: Jaej Kim

Organization: Samsung Medical Center

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: PPI+placebo

Type: Placebo Comparator

Label: PPI+ES

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov