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The Value of I-Scan and Confocal Laser Endomicroscopy for the Assessment of Chronic Inflammatory Bowel Disease

NCT02481687 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2018-01-17

No results posted yet for this study

Summary

Recently, Confocal Laser Endomicroscopy (CLE) has been developed as a novel technique that actually enables in vivo microscopic analysis of the gastrointestinal tract, during ongoing endoscopy. The potential role of CLE has been explored in pathology of both upper and lower gastrointestinal tract, showing good accuracy for predicting the final histopathological diagnosis, based on immediate evaluation of tissue and vascular patterns. Because of its minute scanning area, this techology is best used in conjunction with other "red-flag" techniques to screen the mucosa for areas of interest, which can then be examined by CLE for a histological diagnosis. I-scan technology (Pentax, Tokyo, Japan) is a new image-enhanced endoscopic technique that can achieve a virtual chromoendoscopy, but until now there have been no studies to determine the role of this technology in the evaluation of activity in inflammatory bowel disease. The study protocol is based on comparing imaging findings of p-CLE in conjunction with I-scan endoscopy with activity score and histological diagnosis of inflammatory bowel disease. CLE might have an important role in IBD patients management, by assessing the inflammation, dysplasia or response to treatment.

Conditions

Interventions

OTHER

Confocal laser endomicroscopy

Probe based confocal laser endomicroscopy is a contrast based technique, consisting of a flexible catheter probe representing a bundle of optical fibers linked to a micro-objective a laser scanning unit and the control and acquisition software. The flexible confocal miniprobes can be passed through the working channels of standard endoscopes. The principle of the technique is based on a laser beam of defined wavelength being focused towards the targeted tissue and the recaptured signal is displayed as 'optical biopsies' in a single horizontal plane. The device was intended to be used for faster diagnosis and evaluation of gut diseases, by allowin in vivo histology.

Sponsors & Collaborators

  • Copenhagen University Hospital at Herlev

    collaborator OTHER

  • University of Medicine and Pharmacy Craiova

    lead OTHER

Principal Investigators

  • Adrian Saftoiu, MD PhD FASGE · University of Medicine and Pharmacy Craiova

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Romania

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02481687 on ClinicalTrials.gov