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

NCT ID: NCT01024621

Last Updated: 2012-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-07-31

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.

Conditions

Intestinal Metaplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

1

confocal laser endomicroscopy

Group Type: EXPERIMENTAL

Endomicroscope

Intervention Type: DEVICE

Pentax EC3870K, Tokyo, Japan

2

standard endoscopy

Group Type: ACTIVE_COMPARATOR

Standard endoscopy

Intervention Type: DEVICE

Pentax EG-2931 gastroscope

Interventions

Endomicroscope

Pentax EC3870K, Tokyo, Japan

Intervention Type: DEVICE

Standard endoscopy

Pentax EG-2931 gastroscope

Intervention Type: DEVICE

Other Intervention Names

Pentax EC3870K endomicroscope; Pentax EC2931 gastroscope (Pentax, Tokyo, Japan)

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Yanqing Li

Chief of the Department of Gastroenterolgoy, Qilu Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanqing Li, PhD. MD.

Role: STUDY_DIRECTOR

Department of Gastroenterology, Qilu Hospital, Shandong University

Locations

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Countries

China

Other Identifiers

2009SDU-QILU-G06

Identifier Type: -

Identifier Source: org_study_id