Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy

Comparison Confocal Laser Endomicroscopy With Conventional Endoscopy for the Detection of Early Gastric Cancers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00851305

Acronym

CLE

Enrollment

1786

Registered

2009-02-25

Start date

2008-08-31

Completion date

2009-07-31

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

Precancerous Conditions, Stomach Neoplasms

Keywords

Stomach, endoscopy, neoplasms

Brief summary

The purpose of this study is to determine whether endomicroscopy can improve the detection of Early Gastric Cancers (EGC).

Detailed description

Endoscopy is proved to be the best method to achieve early diagnosis of gastric cancer (GC). Confocal laser endomicroscopy (CLE), a new diagnostic modality, has been shown to be valuable in increasing the diagnostic yield of colorectal neoplasias, but it is not clear whether CLE is helpful to find out early gastric cancer (EGC).The aim of the study is to investigate the value of CLE in improving the detection of EGCs.

Interventions

DEVICEEndomicroscope (Pentax, Tokyo, Japan)

A Pentax EC3870K endomicroscope which can produce conventional white light endoscopic images and confocal images at the same time with a optical slice thickness of 7 μm, a lateral resolution of 0.7 μm, a scanning depth of 0 to 250 μm, a pixel density of 1024×512 pixels (at an image acquisition rate of 1.6 frames/second)，and a field of view of 475 μm×475 μm.

DEVICEGastroscopes (Pentax, Tokyo, Japan)

Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 45 years old ≤ age \< 80 years old * Patients with dyspeptic symptoms or with gastric premalignant conditions for surveillance gastroscopy

Exclusion criteria

* Known cancers or gastrectomy * Scheduled for endoscopic treatment * Alarm symptoms such as dysphagia, anaemia, gastrointestinal bleeding or obstruction, marked weight loss * Under conditions such as: * ascites * jaundice * liver cirrhosis * impaired renal function * coagulopathy * fever * pregnancy * breastfeeding * Inability to provide informed consent * Known allergy to fluorescein sodium

Design outcomes

Primary

Measure	Time frame
To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy.	one year

Secondary

Measure	Time frame
To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs.	one year

Countries

China

Outcome results

None listed

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