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The Diagnostic Value of Combinatory EUS and ERCP in Unclear Lesions

NCT ID: NCT03504293

Last Updated: 2020-12-22

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

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2020-12-15

Brief Summary

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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

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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

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Neoplasms Biliary Stricture Biliary Tract Neoplasms Biliary Tract Diseases

Keywords

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Endosonography Endoscopic retrograde choledochography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Combinatory EUS and ERCP

EUS performed as a supplementary procedure in addition to ERCP

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Per Hedenström

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Riadh Sadik, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital, Gothenburg

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EUS-ERCP Study

Identifier Type: -

Identifier Source: org_study_id