Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy (CLE)

July 16, 2012 updated by: Yanqing Li, Shandong University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1786

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 confocal laser endomicroscopy
Targeted biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by confocal laser endomicroscopy.
Device: 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.
Other Names:
  • Pentax EC3870K endomicroscope
Active Comparator: 2 Conventional endoscopy
Routine biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by conventional endoscopy.
Device: Gastroscopes (Pentax, Tokyo, Japan)
Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)
Other Names:
  • Pentax EG-2940 gastroscopes (Pentax, Tokyo, Japan)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Estimate)

July 17, 2012

Last Update Submitted That Met QC Criteria

July 16, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008SDU-QILU-G01
  • 2006GG3202022
  • 2007(Ministry of Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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