Clinical Utility of the Spyglass System in Primary Sclerosing Cholangitis (PSC)
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|ClinicalTrials.gov Identifier: NCT01556555|
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : March 16, 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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||46 participants|
|Official Title:||Prospective Evaluation of the Clinical Utility of Peroral Cholangiopancreatoscopy With the Spyglass System in Patients With Sclerosing Cholangitis|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||October 2011|
Primary sclerosing cholangitis
Patients with a definite diagnosis of sclerosing cholangitis and a clinical indication for ERCP.
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
|Karolinska University Hospital, Huddinge|
|Stockholm, Sweden, 14186|
|Principal Investigator:||Annika Bergquist, Assoc prof||Karolinska University Hospital|