CH-EUS in Diagnosis of Inoperable Bile Duct Tumors

Not Applicable

• Conditions: Inoperable Disease; Bile Duct Cancer
• Interventions: Procedure: Endoscopic ultrasound with fine needle biopsy

• Registration Number: NCT05418543
• Lead Sponsor: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-06
• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-14
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-15
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CH-EUS-FNA	Endoscopic ultrasound with fine needle biopsy	-
EUS-FNA	Endoscopic ultrasound with fine needle biopsy	-

Primary Outcome Measures

Name	Time	Method
CH-EUS FNA has higher diagnostic accuracy for bile tuct tumors	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.

Trial Locations

Locations (1)

IRGH "O. Fodor"; 🇷🇴 Cluj-Napoca, Cluj, Romania