sefulness of l-menthol preparation for endoscopic diagnosis of intestinal metaplasia by Linked Color Imaging

Phase 2

• Conditions: Gastrointestinal metaplasia

• Registration Number: JPRN-jRCTs051190115
• Lead Sponsor: KATOU Mototsugu

Brief Summary

We examined the effect of l-menthol spray on the endoscopic diagnosis of intestinal epithelialization in LCI. Patients with suspected intestinal epithelialization were included in the study. We found that l-menthol increased the visibility of intestinal epithelialization in LCI compared to WLI. l-menthol spray improved the endoscopic diagnosis of gastrointestinal epithelialization in LCI.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-04
• Study Completion: 2020-10-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1 Men and women aged 50 to 80 at the time of consent acquisition
(2) A person who, after receiving sufficient explanation for participation in this research, has obtained a consent based on the free will of the research subject person after sufficient understanding

Exclusion Criteria

1) Patients who can not be biopsied while taking basic diseases or antithrombotic drugs, those who have stomach bleeding
2) Person after gastrectomy
3) In addition, those who the research principal doctor judged inappropriate as the research subject

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the rating scale of visibility determined by the three judges.

Secondary Outcome Measures

Name	Time	Method
1) Comparison of LCI and WLI visibility of the site of intestinal metaplasia before drug spraying<br>2) Comparison of the LCI range and the WLI range of intestinal metaplasia before drug spraying<br>3) Comparison of LCI and WLI visibility of the site of intestinal metaplasia after drug spraying<br>4) Comparison of the LCI range and the WLI range of intestinal metaplasia after drug spraying<br>5) Comparison of intestinal metaplasia range before and after drug application with LCI<br>6) Correct diagnosis rate by histopathological diagnosis of intestinal metaplasia (lavender) and non-intestinal metaplasia (non-lavender) diagnosed with LCI<br>7) Comparison of LCI chromaticity and WLI chromaticity of region of interest (Target Of Interest: LOI) before drug application<br>8) Comparison of TOI LCI chromaticity and WLI chromaticity after drug application<br>9) Color comparison of TOI before and after drug application with LCI<br>10) Comparison of color of TOI before and after drug application with WLI