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CH-EUS in Diagnosis of Inoperable Bile Duct Tumors

I

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

Status

Enrolling

Conditions

Bile Duct Cancer
Inoperable Disease

Treatments

Procedure: Endoscopic ultrasound with fine needle biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT05418543
1509/03.02.2022

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

EUS-FNA
Experimental group
Treatment:
Procedure: Endoscopic ultrasound with fine needle biopsy
CH-EUS-FNA
Experimental group
Treatment:
Procedure: Endoscopic ultrasound with fine needle biopsy

Trial contacts and locations

1

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Central trial contact

Rares-Ilie Orzan, PHD student

Data sourced from clinicaltrials.gov

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