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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University
ClinicalTrials.gov Identifier:
NCT00851305
First received: February 24, 2009
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention
Stomach Neoplasms
Precancerous Conditions
 Device: Endomicroscope (Pentax, Tokyo, Japan)
Device: Gastroscopes (Pentax, Tokyo, Japan)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison Confocal Laser Endomicroscopy With Conventional Endoscopy for the Detection of Early Gastric Cancers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shandong University:

Primary Outcome Measures:
  • To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs. [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 1786
Study Start Date: August 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851305

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

No publications provided

Responsible Party: Yanqing Li, Chief of the Department of Gastroenterology, Shandong University
ClinicalTrials.gov Identifier: NCT00851305     History of Changes
Other Study ID Numbers: 2008SDU-QILU-G01, 2006GG3202022, 2007(Ministry of Health)
Study First Received: February 24, 2009
Last Updated: July 16, 2012
Health Authority: China: Ministry of Health

Keywords provided by Shandong University:
Stomach
endoscopy
neoplasms

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Precancerous Conditions
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 19, 2013