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NCT03504293 Clinical Trial

The Diagnostic Value of Combinatory EUS and ERCP in Unclear Lesions

Neoplasms Clinical Trial

Official title:
Sahlgrenska EUS ERCP Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03504293
Other study ID # EUS-ERCP Study
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date December 15, 2020

Study information
Verified date December 2020
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

ERCP with brush cytology has a poor to moderate accuracy in unclear biliary lesions. Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology may override some of these shortcomings. The current prospective study, performed in a tertiary University center, aims to study the feasibility, the accuracy and the clinical value of combinatory ERCP and EUS in unclear biliary lesions.

Description:

The eligible study participants with unclear biliary lesions referred for an ERCP to the Sahlgrenska Univeristy Hospital endoscopy unit will be subjected to ERCP with/without brush cytology followed by EUS with/without FNA. The results of ERCP and EUS will be compared to the pathology report of surgical specimens in resected patients or to clinical follow up at 12 months post-EUS in non-resected patients.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date December 15, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with unclear lesions or strictures in the biliary tract referred for endoscopy work up Exclusion Criteria: - Patients unwilling to participate - Patients unfit for EUS and ERCP

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Combinatory EUS and ERCP
EUS performed as a supplementary procedure in addition to ERCP

Locations
Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy Overall accuracy of ERCP and EUS 12 months post-EUS
Secondary Adverse event rate The number of patients ending up with some type of complication related to ERCP or EUS 30 days post-EUS
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