REVerse Intestinal Metaplasia in the Stomach (REVISE)

Phase 2

Not yet recruiting

• Conditions: Gastric Intestinal Metaplasia; Gastric Precancer

• Registration Number: NCT06590454
• Lead Sponsor: Duke University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-9-9
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Inclusion Criteria:<br><br> - Adults (including men, women, and non-binary individuals) over age 18 with known GIM<br> with at least one high-risk feature (extensive vs limited, incomplete or mixed-type<br> GIM, family history of stomach cancer),<br><br> - Ability to provide informed consent,<br><br> - Evidence of prior but not active H. pylori infection<br><br>Exclusion Criteria:<br><br> - Active gastric cancer diagnosis,<br><br> - High-risk of bleeding complications due to anticoagulants or underlying medical<br> condition,<br><br> - Pregnancy (which is a contraindication to non-emergent endoscopy due to anesthesia<br> risks)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the number of clinical biopsies with evidence of gastric intestinal metaplasia

Secondary Outcome Measures

Name	Time	Method
Number of clinical biopsies with presence of inflammation;Number of clinical biopsies with evidence of gastric intestinal metaplasia;Number of clinical biopsies with complete gastric intestinal metaplasia;Number of clinical biopsies with incomplete gastric intestinal metaplasia;Number of clinical biopsies with presence of parietal cells (reversal of atrophy)