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

February 15, 2020 updated by: Doc. (Ass. prof.) Jan Martinek, MD, PhD, AGAF, Institute for Clinical and Experimental Medicine

Probe-based Confocal Laser Endomicroscopy in Accurate Histopathologic Diagnosis of Neoplastic Gastrointestinal Lesion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Confocal laser endomicroscopy (CLE) has been developed to overcome the limitations of the current endoscopic sampling techniques. CLE allows detailed examination of cellular structures since it provides images very similar to images which a pathologist can see in the microscope. At present, probe based CLE (pCLE) is the only available technology of endomicroscopy. Before optical biopsy, a fluorescein is given intravenously and then fluorescent light coming from a horizontal special focal plane is detected during pCLE of the digestive system.

CLE provide real-time histopathological diagnosis and can lead to an immediate endoscopic treatment in case of early esophageal and gastric neoplasia.

Patients after treatment of Barrett's esophagus related esophageal neoplasia (dysplasia or early cancer) should be surveilled endoscopically with biopsies to rule out relapse of Barrett's esophagus or neoplasia.

Project A - pCLE in the detection of esophageal and gastric lesions:

We plan to investigate the diagnostic accuracy of pCLE (compared to standard histopathology) in patients with endoscopically diagnosed early esophageal and gastric lesions.

Project B - pCLE in the detection of persistent/recurrent intestinal metaplasia/dysplasia in patients after endoscopic treatment of BORN:

Investigators plan to perform a prospective cross-over study comparing the diagnostic accuracy and sensitivity of pCLE with standard biopsies in patients after completed endoscopic treatment of BORN. Surveillance endoscopies are focused on detection of persistent/recurrent IM or dysplasia (ev. neoplasia). BORN is defined as low-grade dysplasia (confirmed by a specialized esophageal pathologist) or as high grade dysplasia or early adenocarcinoma. Investigators will also examine the ability of pCLE to detect buried glands after radiofrequency ablation.

Methods:

Project A:

Patients referred to our department with a suspect and endoscopically visible lesion in the esophagus or stomach will undergo pCLE during a standard upper GI endoscopy with pCLE. After a real-time diagnosis (made by the endoscopist), the standard tissue sampling (biopsies, endoscopic resection or dissection) followed by a standard histopathological tissue assessment will follow.

Project B:

During one of surveillance endoscopies in patients after finishing the endoscopic treatment of BORN (interval depends on baseline diagnosis), pCLE will be performed in the cardia, neo-Z-line, esophagus body and visible lesions, and images will be stored. Thereafter, standard biopsies will be taken and sent for histopathological analysis.

For optical biopsy, endoscopist (real time) and two expert pathologists will independently blindly evaluate each "optical specimen". The standard biopsy specimen will be assessed independently by a pathologist not assessing the optical biopsy. Results of optical biopsy will be compared with results of standard biopsy.

Main hypothesis:

Project A:

pCLE is not inferior to standard biopsy (or resection) specimen in histopathological diagnosing of esophageal/gastric lesions.

Project B:

pCLE is not inferior compared to standard biopsies in detecting persistent/recurrent IM, recurrent neoplasia and buried glands.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Prague
      • Prague 4, Prague, Czechia, 14021
        • Institute for Clinical and Experimental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
till 3 day after procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity of the procedure
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Clinical and Experimental Medicine

Investigators

  • Principal Investigator: Jan Martinek, MD. PhD., Institute for Clinical and Experimental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 15, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-27648A
  • G280 (Other Identifier: IKEM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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