The Diagnostic Value of Combinatory EUS and ERCP in Unclear Lesions

Sahlgrenska University Hospital90 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Neoplasms Biliary Stricture Biliary Tract Neoplasms Biliary Tract Diseases

Interventions

Combinatory EUS and ERCPPROCEDURE

EUS performed as a supplementary procedure in addition to ERCP

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Outcomes

Primary Outcomes

Diagnostic accuracy

Overall accuracy of ERCP and EUS

Time frame: 12 months post-EUS

Secondary Outcomes

Adverse event rate

The number of patients ending up with some type of complication related to ERCP or EUS

Time frame: 30 days post-EUS

Data from ClinicalTrials.gov

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