the efficacy and safety of rebamipide to regress gastric atrophy in patients who have undergone the ESD/EMR operation due to early stage gastric cancer or adenoma

Not Applicable

Recruiting

• Conditions: Diseases of the digestive system

• Registration Number: KCT0001915
• Lead Sponsor: Kyungpook National University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Patients who have undergone the ESD/EMR due to EGC or adenoma
1. Both men and women aged between 20 and 65 at the time of informed consent
2. Those who have undergone the ESD/EMR due to EGC or adenoma
3. Those who participated in the trial by signing an informed consent form

Exclusion Criteria

1. Hypersensitivity to rebamipide
2. Pregnant or breast-feeding women and women of childbearing potential
3. History of mental illness, alcoholism, or drug abuse
4. Concurrent serious heart disease, pulmonary disease or endocrine disorder
5. Participation in another clinical trial within the past 4 weeks
6. History of taking NSAIDs, anticoagulants, prostaglandin E, or steroids within 2 weeks before enrollment
7. Use of other mucosal protective agents which may interfere with the activity of rebamipide
8. Detection during an endoscopy of another gastrointestinal disease requiring treatment (peptic ulcer or other malignant diseases)
9. History of pancreatobiliary disease (excluding asymptomatic cholelithiasis), inflammatory bowel disease, chronic liver disease, or chronic kidney disease
10. Positive UBT at screening after H. pylori eradication
11. Conversion from positive to negative H. pylori test by eradication therapy before screening
12. Subject’s rejection of participation in the trial
13. History of gastrectomy

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histological regression of atrophic gastritis: compare regression of atrophic gastritis between the groups

Secondary Outcome Measures

Name	Time	Method
ong-term safety of rebamipide