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Completed

NCT Number: NCT01880606

Endomicroscopy in Primary Sclerosing Cholangitis Related Inflammatory Bowel Disease Surveillance

Evaluation of the efficacy of laser-based endomicroscopy as a complement to white-light colonoscopy and chromoendoscopy for early detection of colon dysplasia in patients with PSC-IBD. White-light colonoscopy is a routinely used procedure in colorectal cancer surveillance programs. However, it does not permit detection of early dysplastic lesions. Chromoendoscopy by applying a dye (indigo-carmine) through the colonoscope helps to identify flat lesions but is not suitable for accurate endoscopic diagnosis of dysplasia and intraepithelial neoplasia Under this aim we will perform a clinical study evaluating a newly developed technique allowing for in vivo confocal microscopy assessment of the colon mucosa using laser-based endomicroscopy together with intravenous administration of fluorescein (FITC).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastro Center Karolinska University Hospital

Stockholm, 14186, Sweden

About this study

Chromoendoscopy by applying a dye (indigo-carmine) through the colonoscop is the new standard for cancer surveillance in patients with IBD . It gives the opportunity to identify suspected areas of dysplasia and to take targeted biopsies. The diagnostic accuracy improves and the chances for detecting dysplastic areas increase. In recent years new endoscopic techniques have been developed, including laser-based endomicroscopy. There is an increasing need for structured evaluation of the efficiency of these techniques. Laser-based endomicroscopy, taking in vivo confocal microscopy pictures during the colonoscopy examination, is the most promising new method. This method is established in highly rated centers for the early diagnosis of neoplasia in the bile ducts and the esophagus but its role for detection early malignancies in the colon is not known and studying this issue is of very high clinical value.

Specific questions: Does the use of laser-based endomicroscopy increase the chances for early detection of dysplasia? What is the intraobserver variability? What is the learning curve for interpretation of confocal microscopy pictures? Material and methods: A laser-based endomicroscope (Cellvizio®, Mauna Kea Technologies) have been acquired and the examination procedure has been established at the Unit for Gastroenterology and Hepatology, Karolinska University Hospital Huddinge. Eighty patients with PSC and IBD included in annual surveillance with colonoscopy with routine biopsy regime will be included in the study. After informed consent, patients are investigated with laser-based endomicroscopy during surveillance colonoscopy. Each colonic segment will be examined before and after staining with indigo-carmin. After intra-venous fluorescein (FITC) injection, all macroscopically abnormal lesions will be examined by endomicroscopy. Intravenous administration of FITC makes it possible to obtain in vivo microscopic pictures with up to a 1000x magnification of the colon mucosa. The Cellvizio® technique allows for evaluation of epithelial and endothelial cell structures in areas with suspicious changes as well as for acquisition of directed biopsies. Confocal pictures from all sites where biopsies have been taken are saved for future blind re-evaluation. The biopsies are taken according to the routine standard with minimum of 2 biopsies from each 10 cm in the colon. For the immunological and microbiological (specific aim 2) parts of the study, additional 16 biopsies are gathered from left, transverse, and right colon. All the laser-based endomicroscopy pictures and sequences are saved for further evaluation and further application in arranging pedagogical sessions for evaluation of the learning curve of the technique.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnosis of PSC-IBD

Exclusion criteria

  • the lack of informed consent, allergy to fluorescein, B-blockers treatment

Treatment and study plan

colonoscopy with endomicroscopy

Procedure

Examination will be performed in two steps. On the way from rectum to caecum, mucosa will be evaluated with white light endoscopy and random biopsies will be taken according to the routine standard with minimum of 2 biopsies from each 10 cm of colon. On the way back (from caecum to rectum) mucosa will be stained with indigo carmine and after intravenous fluorescein injection all macroscopically abnormal lesions will be examined by endomicroscopy and biopsied. Additionally, all places where random biopsies were taken will be also examined with endomicrosopy.

Primary outcomes

  1. Sensitivity and specificity of endomicroscopy versus white light endoscopy in detection of dysplastic lesions in colon using histological assesment as a gold standard.

    Time frame: one year

Secondary outcomes

  1. measurement of number of dysplastic lesions discovered by adding pCLE to white-light endoscopy

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

Probe-based Confocal Laser Endomicroscopy in Colonoscopic Surveillance of Patients With Primary Slerosing Cholangitis Related Inflammatory Bowel Disease (PSC-IBD)

Acronym: pCLE-PSC-IBD

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jun 19, 2013
Registry last updated
Apr 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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