Trial record 9 of 32 for:    Open Studies | "Cholangitis"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Karolinska University Hospital
Sponsor:
Information provided by (Responsible Party):
Aldona Dlugosz, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01880606
First received: June 12, 2013
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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 Intervention
Primary Sclerosing Cholangitis
Inflammatory Bowel Disease
Procedure: colonoscopy with endomicroscopy

Study Type: Observational [Patient Registry]
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • measurement of number of dysplastic lesions discovered by adding pCLE to white-light endoscopy [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum, tissue


Estimated Enrollment: 80
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • clinical diagnosis of PSC-IBD

Exclusion Criteria:

  • the lack of informed consent, allergy to fluorescein, B-blockers treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01880606

Contacts
Contact: Aldona Dlugosz, PhD 0046858582343 aldona.dlugosz@karolinska.se

Locations
Sweden
Gastro Center Karolinska University Hospital Recruiting
Stockholm, Sweden, 14186
Contact: Annika Bergquist, PhD    004685852465    annika.bergquist@karolinska.se   
Sub-Investigator: Ammar Barakat, MD         
Principal Investigator: Aldona Dlugosz, MD, PhD         
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Study Chair: Annika Bergquist, PhD Gastro Center Karolinska Institute
  More Information

No publications provided

Responsible Party: Aldona Dlugosz, MD, PhD consultant, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01880606     History of Changes
Other Study ID Numbers: PSC-IBD2012
Study First Received: June 12, 2013
Last Updated: June 14, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Inflammatory Bowel Diseases
Intestinal Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 20, 2014