Clinical Utility of the Spyglass System in Primary Sclerosing Cholangitis (PSC)
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.
|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|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556555
|Karolinska University Hospital, Huddinge|
|Stockholm, Sweden, 14186|
|Principal Investigator:||Annika Bergquist, Assoc prof||Karolinska University Hospital|