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Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy

NCT ID: NCT00851305

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1786 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Stomach Neoplasms Precancerous Conditions

Keywords

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Stomach endoscopy neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1 confocal laser endomicroscopy

Targeted biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by confocal laser endomicroscopy.

Group Type EXPERIMENTAL

Endomicroscope (Pentax, Tokyo, Japan)

Intervention Type DEVICE

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.

2 Conventional endoscopy

Routine biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by conventional endoscopy.

Group Type ACTIVE_COMPARATOR

Gastroscopes (Pentax, Tokyo, Japan)

Intervention Type DEVICE

Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)

Interventions

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Endomicroscope (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.

Intervention Type DEVICE

Gastroscopes (Pentax, Tokyo, Japan)

Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)

Intervention Type DEVICE

Other Intervention Names

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Pentax EC3870K endomicroscope Pentax EG-2940 gastroscopes (Pentax, Tokyo, Japan)

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Chief of the Department of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, PhD. MD.

Role: STUDY_DIRECTOR

Department of Gastroenterology, Qilu Hospital, Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2006GG3202022

Identifier Type: -

Identifier Source: secondary_id

2007(Ministry of Health)

Identifier Type: -

Identifier Source: secondary_id

2008SDU-QILU-G01

Identifier Type: -

Identifier Source: org_study_id