Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy
CLE
Comparison Confocal Laser Endomicroscopy With Conventional Endoscopy for the Detection of Early Gastric Cancers
3 other identifiers
interventional
1,786
1 country
1
Brief Summary
The purpose of this study is to determine whether endomicroscopy can improve the detection of Early Gastric Cancers (EGC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 24, 2009
CompletedFirst Posted
Study publicly available on registry
February 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJuly 17, 2012
July 1, 2012
11 months
February 24, 2009
July 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy.
one year
Secondary Outcomes (1)
To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs.
one year
Study Arms (2)
1 confocal laser endomicroscopy
EXPERIMENTALTargeted biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by confocal laser endomicroscopy.
2 Conventional endoscopy
ACTIVE COMPARATORRoutine biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by conventional endoscopy.
Interventions
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.
Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)
Eligibility Criteria
You may qualify if:
- years old ≤ age \< 80 years old
- Patients with dyspeptic symptoms or with gastric premalignant conditions for surveillance gastroscopy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yanqing Li, PhD. MD.
Department of Gastroenterology, Qilu Hospital, Shandong University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of the Department of Gastroenterology
Study Record Dates
First Submitted
February 24, 2009
First Posted
February 25, 2009
Study Start
August 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
July 17, 2012
Record last verified: 2012-07