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

Not Applicable

Completed

• Conditions: Intestinal Metaplasia
• Interventions: Device: Endomicroscope; Device: Standard endoscopy

• Registration Number: NCT01024621
• Lead Sponsor: Shandong University

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 Description

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• 40 years old ≤ age < 80 years old
• Patients with dyspeptic symptoms and/or with certain risk factors of gastric intestinal metaplasia
• Able to give informed consent.

Exclusion Criteria

• Esophageal, gastric or duodenal cancer or other malignancy
• Known GIM or intraepithelial neoplasia in upper GI tract
• Scheduled for endoscopic therapy
• History of upper GI tract surgery
• Reflux esophagitis or acute gastritis or peptic ulcers
• Acute upper gastrointestinal bleeding
• Coagulopathy or bleeding disorders
• Allergy to fluorescein sodium
• Pregnant or breast-feeding (for females)
• Impaired renal function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Endomicroscope	confocal laser endomicroscopy
2	Standard endoscopy	standard endoscopy

Primary Outcome Measures

Name	Time	Method
the diagnostic yield of gastric intestinal metaplasia	Seven months

Secondary Outcome Measures

Name	Time	Method
the biopsy number needed in each group	Seven months

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China