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

Intestinal Metaplasia Clinical Trial

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 Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024621
• Other study ID #: 2009SDU-QILU-G06
• Status: Completed
• Phase: N/A
• First received: December 2, 2009
• Last updated: July 16, 2012
• Start date: November 2009
• Est. completion date: July 2010

Study information

• Verified date: July 2012
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastritis, Atrophic
• Intestinal Metaplasia
• Metaplasia

Intervention

Device:
• Endomicroscope
Pentax EC3870K, Tokyo, Japan
• Standard endoscopy
Pentax EG-2931 gastroscope

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the diagnostic yield of gastric intestinal metaplasia		Seven months	No
Secondary	the biopsy number needed in each group		Seven months	No