PCLE for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma
NCT ID: NCT02515721
Last Updated: 2015-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
242 participants
INTERVENTIONAL
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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pCLE-TB
Patients will receive white-light endoscopic imaging, followed by probe-based Confocal Laser Endomicroscopy scanning on suspected lesions and 5 standardized locations. Then targeted Biopsies will be performed on locations with intestinal metaplasia, intraepithelial neoplasia, and carcinoma.
pCLE-TB
Patients will receive white-light endoscopic imaging, followed by probe-based Confocal Laser Endomicroscopy scanning on suspected lesions and 5 standardized locations. Then targeted Biopsies will be performed on locations with intestinal metaplasia, intraepithelial neoplasia, and carcinoma.
Virtual Chromoendoscopy -SB
Patients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions.
virtual chromoendoscopy-TB
Patients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions.
Interventions
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pCLE-TB
Patients will receive white-light endoscopic imaging, followed by probe-based Confocal Laser Endomicroscopy scanning on suspected lesions and 5 standardized locations. Then targeted Biopsies will be performed on locations with intestinal metaplasia, intraepithelial neoplasia, and carcinoma.
virtual chromoendoscopy-TB
Patients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients with previous pathologic diagnosis of atrophic gastritis, gastric intestinal metaplasia, and low-grade intraepithelial neoplasia;
* agree to give written informed consent.
Exclusion Criteria
* Patients under conditions unsuitable for performing CLE including coagulopathy (prothrombin time \<50% of control, partial thromboplastin time \>50 s), impaired renal function (creatinine level \>1.2 mg/dL), pregnancy or breastfeeding, and known allergy to fluorescein sodium;
* Inability to provide informed consent
18 Years
80 Years
ALL
No
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Tongji Hospital
OTHER
Zhejiang University
OTHER
Shandong University
OTHER
Responsible Party
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Yanqing Li
Chief of the department of Gastroenterology
Locations
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Endoscopic unit of Qilu Hospital Shandong University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Zuo XL, Li Z, Li CQ, Zheng YY, Xu LD, Chen J, Lin R, Song J, Yu CH, Yue M, Zhou Q, Liu ZY, Li YQ. Probe-based endomicroscopy for in vivo detection of gastric intestinal metaplasia and neoplasia: a multicenter randomized controlled trial. Endoscopy. 2017 Nov;49(11):1033-1042. doi: 10.1055/s-0043-115382. Epub 2017 Jul 28.
Other Identifiers
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2015SDU-QILU-G06
Identifier Type: -
Identifier Source: org_study_id
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