pCLE in the Detection of Esophageal and Gastric Lesions and Intestinal Metaplasia or Dysplasia in Patients After Endoscopic Treatment of BORN
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|ClinicalTrials.gov Identifier: NCT02922049|
Recruitment Status : Completed
First Posted : October 3, 2016
Last Update Posted : February 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Barrett's Esophagus||Other: Biopsies with histopathology||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Probe-based Confocal Laser Endomicroscopy in Accurate Histopathologic Diagnosis of Neoplastic Gastrointestinal Lesion|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||April 2019|
|Actual Study Completion Date :||January 2020|
pCLE vs. biopsies with histopathology
The investigators will compare diagnostic accuracy and sensitivity of pCLE with standard biopsies in patients with esophageal and gastric lesions and in patients after completed endoscopic treatment of BORN.
All samples taken by biopsies will be correlated with the images taken by pCLE in the detection of lesions, intestinal metaplasia, dysplasia and buried glands.
Other: Biopsies with histopathology
All samples taken by biopsies will be correlated with the images taken by CLE.
- Detection of persistent or recurrent intestinal metaplasia/dysplasia and esophageal and gastric lesions by confocal laser endomicroscopy and classic histopathology [ Time Frame: till 3 day after procedure ]
- Sensitivity and specificity of the procedure [ Time Frame: through study completion, an average of 1 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): NCT02922049
|Institute for Clinical and Experimental Medicine|
|Prague 4, Prague, Czechia, 14021|
|Principal Investigator:||Jan Martinek, MD. PhD.||Institute for Clinical and Experimental Medicine|