REVerse Intestinal Metaplasia in the Stomach (REVISE)

Launched by DUKE UNIVERSITY · Sep 9, 2024

Keywords

ClinConnect Summary

The REVISE trial is studying a treatment called Pyrvinium to see if it can help reverse a condition known as gastric intestinal metaplasia (GIM), which can increase the risk of stomach cancer. In this study, researchers will compare the effects of Pyrvinium to a placebo (a substance with no active ingredients) to determine how well it works in improving GIM. They will also create small lab samples from patients' stomach tissues to test the treatment's effects and explore other potential drugs that could help with this condition.

To participate in this trial, you must be an adult over the age of 18 who has been diagnosed with gastric intestinal metaplasia and has certain high-risk features, such as a family history of stomach cancer. Participants should also have had a previous but currently inactive infection from a bacteria called H. pylori. However, those with active stomach cancer, certain bleeding risks, or those who are pregnant cannot join the study. If eligible, participants can expect to undergo assessments before and after treatment to evaluate how well the Pyrvinium works. It’s important to note that this trial is not yet recruiting participants.

Gender

ALL

Eligibility criteria

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