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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Annika Bergquist, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01556555
First received: March 14, 2012
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition
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:

U.S. FDA Resources

Further study details as provided by 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)
Groups/Cohorts
Primary sclerosing cholangitis
Patients with a definite diagnosis of sclerosing cholangitis and a clinical indication for ERCP.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with SC, sclerosing cholangitis, who is undergoing ERCP, (Endoscopic Retrograde Cholangio and Pancreaticography)

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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

No publications provided

Responsible Party: Annika Bergquist, Head of department of gastroenterology and hepatology, associate professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01556555     History of Changes
Other Study ID Numbers: 552/03
Study First Received: March 14, 2012
Last Updated: March 15, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:
Sclerosing cholangitis
Spyglass
Endoscopic retrograde cholangiopancreaticography

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013