CH-EUS in Diagnosis of Inoperable Bile Duct Tumors

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