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Endomicroscopy in Primary Sclerosing Cholangitis Related Inflammatory Bowel Disease Surveillance (pCLE-PSC-IBD)

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. Identifier: NCT01880606
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : April 27, 2015
Information provided by (Responsible Party):
Aldona Dlugosz, Karolinska University Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment
Primary Sclerosing Cholangitis Inflammatory Bowel Disease Procedure: colonoscopy with endomicroscopy

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 69 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Probe-based Confocal Laser Endomicroscopy in Colonoscopic Surveillance of Patients With Primary Slerosing Cholangitis Related Inflammatory Bowel Disease (PSC-IBD)
Study Start Date : August 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 2014

Group/Cohort Intervention/treatment
patients with PSC-IBD
Only patients, colonoscopy with endomicroscopy
Procedure: colonoscopy with endomicroscopy
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 Outcome Measures :
  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 Outcome Measures :
  1. measurement of number of dysplastic lesions discovered by adding pCLE to white-light endoscopy [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
whole blood, serum, tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Eighty patients with PSC and IBD included in annual surveillance with colonoscopy with routine biopsy regime will be included in the study.

Inclusion Criteria:

  • clinical diagnosis of PSC-IBD

Exclusion Criteria:

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

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 identifier (NCT number): NCT01880606

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Gastro Center Karolinska University Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
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Study Chair: Annika Bergquist, PhD Gastro Center Karolinska Institute

Additional Information:

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Responsible Party: Aldona Dlugosz, MD, PhD consultant, Karolinska University Hospital Identifier: NCT01880606     History of Changes
Other Study ID Numbers: PSC-IBD2012
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: April 27, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Cholangitis, Sclerosing
Gastrointestinal Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases