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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00851305
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : July 17, 2012
Information provided by (Responsible Party):
Yanqing Li, Shandong University

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

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Precancerous Conditions Device: Endomicroscope (Pentax, Tokyo, Japan) Device: Gastroscopes (Pentax, Tokyo, Japan) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1786 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison Confocal Laser Endomicroscopy With Conventional Endoscopy for the Detection of Early Gastric Cancers
Study Start Date : August 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

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 Name: 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 Name: Pentax EG-2940 gastroscopes (Pentax, Tokyo, Japan)

Primary Outcome Measures :
  1. To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs. [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00851305

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China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
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Study Director: Yanqing Li, PhD. MD. Department of Gastroenterology, Qilu Hospital, Shandong University

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Responsible Party: Yanqing Li, Chief of the Department of Gastroenterology, Shandong University Identifier: NCT00851305     History of Changes
Other Study ID Numbers: 2008SDU-QILU-G01
2007(Ministry of Health)
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012
Keywords provided by Yanqing Li, Shandong University:
Additional relevant MeSH terms:
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Stomach Neoplasms
Precancerous Conditions
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases