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

JRCT ID: jRCTs051190115

Registered date:04/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gastrointestinal metaplasia
• Date of first enrollment: 21/04/2020
• Target sample size: 42
• Study type: Interventional
• Intervention(s): Spray of MINCLEA Spraying Solution

Outcome(s)

• Primary Outcome: Comparison of the rating scale of visibility determined by the three judges.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: KATOU Mototsugu
• Source(s) of Monetary Support: NIHON PHARMACEUTICAL CO., LTD