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Clinical Trials/NCT05418543
NCT05418543
Unknown
N/A

Contrast-enhanced Endoscopic Ultrasound in Diagnosis of Inoperable Bile Duct Tumors

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor1 site in 1 country40 target enrollmentJanuary 1, 2022
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ConditionsInoperable DiseaseBile Duct Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Inoperable Disease
Sponsor
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Enrollment
40
Locations
1
Primary Endpoint
CH-EUS FNA has higher diagnostic accuracy for bile tuct tumors
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

VALIDATION OF THE SUPERIORITY OF CONTRAST ENHANCED ENDOSCOPY TO STANDARD ENDOSCOPY IN THE DIAGNOSIS OF BILE DUCT TUMORS

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Responsible Party
Principal Investigator
Principal Investigator

Rares-Ilie Orzan

Doctor

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Eligibility Criteria

Inclusion Criteria

  • •Bile duct tumor diagnosed at endoscopic US, CT scan or MRI
  • •INR\<1.5; platelets \> 50.000
  • •written consent form

Exclusion Criteria

  • •INR\>1.5; platelets \< 50.000
  • •duodenal invasion or stenosis
  • •patients denial
  • •previous treatment for hepato-biliary tumors

Outcomes

Primary Outcomes

CH-EUS FNA has higher diagnostic accuracy for bile tuct tumors

Time Frame: one week

To asses if CH-EUS FNB is superior to CH-EUS FNA when assessing bile duct tumors. To determine the diagnostic accuracy, sensitivity and sensibility.

Study Sites (1)

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