Endomicroscopy in Primary Sclerosing Cholangitis Related Inflammatory Bowel Disease Surveillance

NCT01880606 | Completed

• 1 other identifier: PSC-IBD2012
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Sclerosing Cholangitis; Inflammatory Bowel Disease

Outcome Measures

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.

  one year

Secondary Outcomes (1)

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

  one year

Study Arms (1)

patients with PSC-IBD

Only patients, colonoscopy with endomicroscopy

Procedure: colonoscopy with endomicroscopy

Interventions

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.

patients with PSC-IBD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• clinical diagnosis of PSC-IBD

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Gastro Center Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, tissue

MeSH Terms

Conditions

Cholangitis, Sclerosing; Inflammatory Bowel Diseases

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gastroenteritis; Gastrointestinal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Annika Bergquist, PhD

  Gastro Center Karolinska Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD consultant

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 19, 2013
• Study Start: August 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: April 27, 2015

Record last verified: 2015-04

Locations

SE (1)