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

Primary Purpose

Stomach Neoplasms, Precancerous Conditions

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endomicroscope (Pentax, Tokyo, Japan)
Gastroscopes (Pentax, Tokyo, Japan)
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stomach Neoplasms focused on measuring Stomach, endoscopy, neoplasms

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Gastroenterology, Qilu Hospital, Shandong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 confocal laser endomicroscopy

2 Conventional endoscopy

Arm Description

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

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

Outcomes

Primary Outcome Measures

To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy.

Secondary Outcome Measures

To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs.

Full Information

First Posted
February 24, 2009
Last Updated
July 16, 2012
Sponsor
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT00851305
Brief Title
Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy
Acronym
CLE
Official Title
Comparison Confocal Laser Endomicroscopy With Conventional Endoscopy for the Detection of Early Gastric Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Precancerous Conditions
Keywords
Stomach, endoscopy, neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1786 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 confocal laser endomicroscopy
Arm Type
Experimental
Arm Description
Targeted biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by confocal laser endomicroscopy.
Arm Title
2 Conventional endoscopy
Arm Type
Active Comparator
Arm Description
Routine biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by conventional endoscopy.
Intervention Type
Device
Intervention Name(s)
Endomicroscope (Pentax, Tokyo, Japan)
Other Intervention Name(s)
Pentax EC3870K endomicroscope
Intervention Description
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
Intervention Name(s)
Gastroscopes (Pentax, Tokyo, Japan)
Other Intervention Name(s)
Pentax EG-2940 gastroscopes (Pentax, Tokyo, Japan)
Intervention Description
Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)
Primary Outcome Measure Information:
Title
To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy.
Time Frame
one year
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, PhD. MD.
Organizational Affiliation
Department of Gastroenterology, Qilu Hospital, Shandong University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Gastroenterology, Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China

12. IPD Sharing Statement

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Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy

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