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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01556555
First Posted: March 16, 2012
Last Update Posted: March 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Annika Bergquist, Karolinska University Hospital
  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:


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)
Groups/Cohorts
Primary sclerosing cholangitis
Patients with a definite diagnosis of sclerosing cholangitis and a clinical indication for ERCP.

  Eligibility

Information from the National Library of Medicine

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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)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: March 14, 2012
First Posted: March 16, 2012
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by Annika Bergquist, 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