Clinical Utility of the Spyglass System in Primary Sclerosing Cholangitis (PSC)

Last updated: September 8, 2021
Sponsor: Karolinska University Hospital
Overall Status: Completed

Phase

N/A

Condition

Liver Disease

Primary Biliary Cholangitis

Gall Bladder Disorders

Treatment

N/A

Clinical Study ID

NCT01556555
552/03
  • Ages > 18
  • All Genders

Study Summary

This study aim to prospectively evaluate the clinical utility of Spyglass in sclerosing cholangitis patients undergoing endoscopic retrograde cholangiopancreaticography (ERCP). Fifty patients with a definite diagnosis of sclerosing cholangitis and a clinical indication for ERCP from September 2008 and onwards will be investigated with peroral cholangioscopy using Spyglass direct visualization system. Clinical data on all patients will be collected at time of the ERCP including information on the Primary sclerosing cholangitis (PSC) and inflammatory bowel disease (IBD), serum liver function tests and indication for ERCP.

A structured data collection form including information on Majoie Score, macroscopic features of the bile ducts at cholangioscopy, quality of the investigation, technical difficulties, and an overall judgment of whether any abnormalities observed were benign or malignant was completed by the endoscopist in conjunction with the procedure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • sclerosing cholangitis with indication for ERCP
  • Over 18 year
  • informed consent

Exclusion

Exclusion Criteria:

  • Not able to sign informed consent

Study Design

Total Participants: 46
Study Start date:
September 01, 2008
Estimated Completion Date:
October 31, 2011

Connect with a study center

  • Karolinska University Hospital, Huddinge

    Stockholm, 14186
    Sweden

    Site Not Available

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