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

Shandong University

Status: Completed

Conditions: Intestinal Metaplasia

Treatments: Device: Standard endoscopy; Device: Endomicroscope

Study type: Interventional

Funder types: Other

Identifiers

NCT01024621

2009SDU-QILU-G06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups

1

Experimental group

Description:

confocal laser endomicroscopy

Treatment:

Device: Endomicroscope

2

Active Comparator group

Description:

standard endoscopy

Treatment:

Device: Standard endoscopy