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

NCT ID: NCT01556555

Last Updated: 2021-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sclerosing Cholangitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary sclerosing cholangitis

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not able to sign informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Annika Bergquist

Head of department of gastroenterology and hepatology, associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Annika Bergquist, Assoc prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Karolinska University Hospital, Huddinge

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 25826274 (View on PubMed)

Other Identifiers

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552/03

Identifier Type: -

Identifier Source: org_study_id

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