Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy (CLE)
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|ClinicalTrials.gov Identifier: NCT00851305|
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : July 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Stomach Neoplasms Precancerous Conditions||Device: Endomicroscope (Pentax, Tokyo, Japan) Device: Gastroscopes (Pentax, Tokyo, Japan)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1786 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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)
- To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy. [ Time Frame: one year ]
- To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs. [ Time Frame: one year ]
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 ClinicalTrials.gov identifier (NCT number): NCT00851305
|Department of Gastroenterology, Qilu Hospital, Shandong University|
|Jinan, Shandong, China, 250012|
|Study Director:||Yanqing Li, PhD. MD.||Department of Gastroenterology, Qilu Hospital, Shandong University|