NCT03504293

The Diagnostic Value of Combinatory EUS and ERCP in Unclear Lesions

Sahlgrenska EUS ERCP Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms
• Biliary Stricture
• Biliary Tract Neoplasms
• Biliary Tract Diseases

Interventions

Type	Name	Description
PROCEDURE	Combinatory EUS and ERCP	EUS performed as a supplementary procedure in addition to ERCP

Timeline

• Start date: 2010-01-01
• Primary completion: 2020-11-30
• Completion: 2020-12-15
• First posted: 2018-04-20
• Last updated: 2020-12-22

Locations

1 site across 1 country: Sweden