Clinical Trial: Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Conventional Fluorescein Sodium Dosage o.1ml/kg Compared With a Lower Fluorescein Sodium Dosage o.02ml/kg for the Detection of Gastric Intestinal Metaplasia in a High Risk
Brief Summary: The purpose of this study is to assess whether lower fluorescein sodium dosage can perceive the same detection rate per patient and per lesion for the detection of gastric intestinal metaplasia.
Detailed Summary:
Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended.
This study aims to compare the diagnostic yield of gastric intestinal metaplasia from two different fluorescein sodium dosage and assess whether lower fluorescein sodium dosage can perceive the same detection rate per patient and per lesion for the detection of gastric intestinal metaplasia.
Sponsor: Shandong University
Current Primary Outcome:
- Difference of the detection rate of gastric intestinal metaplasia between two fluosecein sodium dosage in a per-pateint analysis [ Time Frame: six months ]
- Difference of the detection rate of gastric intestinal metaplasia between two dosage fluosecein sodium in a per-biopsy analysis [ Time Frame: six months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Shandong University
Dates:
Date Received: August 25, 2015
Date Started: June 2015
Date Completion:
Last Updated: November 7, 2015
Last Verified: August 2015
