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pCLE in the Detection of Esophageal and Gastric Lesions and Intestinal Metaplasia or Dysplasia in Patients After Endoscopic Treatment of BORN

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922049
Recruitment Status : Completed
First Posted : October 3, 2016
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Doc. (Ass. prof.) Jan Martinek, MD, PhD, AGAF, Institute for Clinical and Experimental Medicine

Brief Summary:
To assess diagnostic accuracy and clinical effectiveness including cost-effectiveness analysis of pCLE in patients after finishing the endoscopic treatment of BORN in detecting persistent/recurrent IM, recurrent neoplasia and buried glands.

Condition or disease Intervention/treatment Phase
Barrett's Esophagus Other: Biopsies with histopathology Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Sensitivity and specificity of the procedure [ Time Frame: through study completion, an average of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18
  • macroscopic lesion of esophagus or stomach (Project A)
  • pts after ER/ESD/RFA for BORN (Project B)
  • eradication of BORN and Barrett's esophagus macro- and microscopically (Project B)
  • sign agreement with study

Exclusion Criteria:

  • macroscopic persistence of Barrett's esophagus (e.g. tongues)
  • esophageal varices
  • treatment with anticoagulants
  • allergy to fluorescein
  • polyvalent allergy
  • pregnancy

Information from the National Library of Medicine

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


Locations
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Czechia
Institute for Clinical and Experimental Medicine
Prague 4, Prague, Czechia, 14021
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
Investigators
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Principal Investigator: Jan Martinek, MD. PhD. Institute for Clinical and Experimental Medicine

Publications:

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Responsible Party: Doc. (Ass. prof.) Jan Martinek, MD, PhD, AGAF, Ass. Prof. MD. Ph.D. AGAF, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT02922049    
Other Study ID Numbers: 16-27648A
G280 ( Other Identifier: IKEM )
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Doc. (Ass. prof.) Jan Martinek, MD, PhD, AGAF, Institute for Clinical and Experimental Medicine:
Probe Based Confocal Laser Endomicroscopy (pCLE)
Barrett's esophagus
BORN
Intestinal metaplasia
Additional relevant MeSH terms:
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Barrett Esophagus
Metaplasia
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes