Clinical Trial: Confocal Laser Endomicroscopy for the Detection of Gastric Intestinal Metaplasia: a Randomized Controlled Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of Confocal Laser Endomicroscopy With Standard Endoscopy for the Detection and Evaluation of Gastric Intestinal Metaplasia in a High Risk Population: A Randomiz

Brief Summary: The purpose of this study is to assess whether confocal laser endomicroscopy can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

Detailed Summary: Gastric intestinal metaplasia is a well-known premalignant lesions for intestinal type gastric cancer. However, present guidelines such as the updated Sydney System require multiple biopsies whereas reveal an unsatisfactory yield considering the detection and surveillance of these lesions. Confocal laser endomicroscopy is a newly developed endoscopic device that enables microscopic view of the digestive tract. Previous study has showed high sensitivity and specificity for in vivo diagnosis of gastric intestinal metaplasia using confocal laser endomicroscopy. This study aims to assess the real number of biopsies that can be reduced for the detection of gastric intestinal metaplasia using confocal laser endomicroscopy.
Sponsor: Shandong University

Current Primary Outcome: the diagnostic yield of gastric intestinal metaplasia [ Time Frame: Seven months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: the biopsy number needed in each group [ Time Frame: Seven months ]

Original Secondary Outcome: Same as current

Information By: Shandong University

Dates:
Date Received: December 2, 2009
Date Started: November 2009
Date Completion:
Last Updated: July 16, 2012
Last Verified: July 2012