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

Sclerosing Cholangitis Clinical Trial

Official title:

Prospective Evaluation of the Clinical Utility of Peroral Cholangiopancreatoscopy With the Spyglass System in Patients With Sclerosing Cholangitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556555
• Other study ID #: 552/03
• Status: Completed
• Start date: September 2008
• Est. completion date: October 2011

Study information

• Verified date: September 2021
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not able to sign informed consent

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Sclerosing Cholangitis

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital, Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden,