Endomicroscopy in Primary Sclerosing Cholangitis Related Inflammatory Bowel Disease Surveillance
Condition: Primary Sclerosing Cholangitis; Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Cholangitis; Cholangitis, Sclerosing
Study type: Observational [Patient Registry]

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).
    

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.
    

Intervention name(s): colonoscopy with endomicroscopy
Intervention type(s): Procedure
Intervention description(s): 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.
Observational model: Case-Only
Time perspective: Prospective
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.
      
Biospecimen description: 
      whole blood, serum, tissue