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

This study has been completed.
Information provided by (Responsible Party):
Annika Bergquist, Karolinska University Hospital Identifier:
First received: March 14, 2012
Last updated: March 15, 2012
Last verified: March 2012

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.

Sclerosing Cholangitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Clinical Utility of Peroral Cholangiopancreatoscopy With the Spyglass System in Patients With Sclerosing Cholangitis

Resource links provided by NLM:

Further study details as provided by Annika Bergquist, Karolinska University Hospital:

Enrollment: 46
Study Start Date: September 2008
Study Completion Date: October 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Primary sclerosing cholangitis
Patients with a definite diagnosis of sclerosing cholangitis and a clinical indication for ERCP.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with SC, sclerosing cholangitis, who is undergoing ERCP, (Endoscopic Retrograde Cholangio and Pancreaticography)

Inclusion Criteria:

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

Exclusion Criteria:

  • Not able to sign informed consent
  Contacts and Locations
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Please refer to this study by its identifier: NCT01556555

Karolinska University Hospital, Huddinge
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Principal Investigator: Annika Bergquist, Assoc prof Karolinska University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Annika Bergquist, Head of department of gastroenterology and hepatology, associate professor, Karolinska University Hospital Identifier: NCT01556555     History of Changes
Other Study ID Numbers: 552/03
Study First Received: March 14, 2012
Last Updated: March 15, 2012

Keywords provided by Annika Bergquist, Karolinska University Hospital:
Sclerosing cholangitis
Endoscopic retrograde cholangiopancreaticography

Additional relevant MeSH terms:
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases processed this record on August 23, 2017