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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01024621

Enrollment

168

Registered

2009-12-03

Start date

2009-11-30

Completion date

2010-07-31

Last updated

2012-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Metaplasia

Keywords

gastric intestinal metaplasia, Confocal laser endomicroscopy

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.

Interventions

DEVICEEndomicroscope

Pentax EC3870K, Tokyo, Japan

DEVICEStandard endoscopy

Pentax EG-2931 gastroscope

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
the diagnostic yield of gastric intestinal metaplasia	Seven months

Secondary

Measure	Time frame
the biopsy number needed in each group	Seven months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026