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

Karolinska University Hospital

Status: Completed

Conditions: Sclerosing Cholangitis

Study type: Observational

Funder types: Other

Identifiers

NCT01556555

552/03

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Not able to sign informed consent

Trial design

46 participants in 1 patient group

Primary sclerosing cholangitis

Description:

Patients with a definite diagnosis of sclerosing cholangitis and a clinical indication for ERCP.