Clinical Utility of the Spyglass System in Primary Sclerosing Cholangitis (PSC)
Prospective Evaluation of the Clinical Utility of Peroral Cholangiopancreatoscopy With the Spyglass System in Patients With Sclerosing Cholangitis
1 other identifier
observational
46
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 14, 2012
CompletedFirst Posted
Study publicly available on registry
March 16, 2012
CompletedSeptember 9, 2021
September 1, 2021
2.7 years
March 14, 2012
September 8, 2021
Conditions
Keywords
Study Arms (1)
Primary sclerosing cholangitis
Patients with a definite diagnosis of sclerosing cholangitis and a clinical indication for ERCP.
Eligibility Criteria
Patients with SC, sclerosing cholangitis, who is undergoing ERCP, (Endoscopic Retrograde Cholangio and Pancreaticography)
You may qualify if:
- sclerosing cholangitis with indication for ERCP
- Over 18 year
- informed consent
You may not qualify if:
- Not able to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska University Hospital, Huddinge
Stockholm, 14186, Sweden
Related Publications (1)
Arnelo U, von Seth E, Bergquist A. Prospective evaluation of the clinical utility of single-operator peroral cholangioscopy in patients with primary sclerosing cholangitis. Endoscopy. 2015 Aug;47(8):696-702. doi: 10.1055/s-0034-1391845. Epub 2015 Mar 31.
PMID: 25826274DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annika Bergquist, Assoc prof
Karolinska University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of department of gastroenterology and hepatology, associate professor
Study Record Dates
First Submitted
March 14, 2012
First Posted
March 16, 2012
Study Start
September 1, 2008
Primary Completion
May 1, 2011
Study Completion
October 1, 2011
Last Updated
September 9, 2021
Record last verified: 2021-09