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OpenTrials
Completed

NCT Number: NCT03504293

The Diagnostic Value of Combinatory EUS and ERCP in Unclear Lesions

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.

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Key information

Conditions

Neoplasms Biliary Stricture Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combinatory EUS and ERCP

Procedure

EUS performed as a supplementary procedure in addition to ERCP

Primary outcomes

  1. Diagnostic accuracy

    Time frame: 12 months post-EUS

    Overall accuracy of ERCP and EUS

Secondary outcomes

  1. Adverse event rate

    Time frame: 30 days post-EUS

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

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

Sahlgrenska EUS ERCP Study

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2018
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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