The Diagnostic Value of Combinatory EUS and ERCP in Unclear Lesions

Completed

• Conditions: Neoplasms; Biliary Stricture; Biliary Tract Neoplasms; Biliary Tract Diseases

• Registration Number: NCT03504293
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-01-01
• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-20
• Primary Completion: 2020-11-30
• Status Verified: 2020-12
• Study Completion: 2020-12-15
• Last Update Submitted: 2020-12-19
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	12 months post-EUS	Overall accuracy of ERCP and EUS

Secondary Outcome Measures

Name	Time	Method
Adverse event rate	30 days post-EUS	The number of patients ending up with some type of complication related to ERCP or EUS

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden