Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection?

Kangdong Sacred Heart Hospital290 enrolled

Overview

Treatment strategy of post endoscopic submucosal dissection (ESD) ulcer is not yet conclusive. Rebamipide is a mucosal protective agent widely used in East Asia and has good effect on quality of ulcer healing (QOUH). The investigators will conduct this randomized controlled study to assess the effect of a combination therapy of rebamipide and proton pump inhibitor (PPI) on post ESD ulcer healing.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

290

Conditions

Stomach Ulcer

Interventions

RebamipideDRUG

Rebamipide 100mg Tid for 28days

pantoprazoleDRUG

pantoprazole 40mg qd for 28days

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients underwent ESD for gastric adenoma or cancer Exclusion Criteria: * subjects with previous gastric surgery * subjects taking aspirin, anticoagulant, or antiplatelet agent * subjects having malignancy except gastric cancer * pregnant or breast-feeding women

Locations (1)

Kangdong Sacred Heart Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer

Healing efficacy will be assessed by the change of ulcer size. Quality of Ulcer Healing(QOUH) wil be assessed by nodularity in the healed ulcer by two endoscopist.

Time frame: at 2month after endoscopic submucosal dissection (ESD)

Data from ClinicalTrials.gov

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