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NCT05418543 Clinical Trial

CH-EUS in Diagnosis of Inoperable Bile Duct Tumors

Bile Duct Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05418543
Other study ID # 1509/03.02.2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date December 30, 2022

Study information
Verified date June 2022
Source Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Contact Rares-Ilie Orzan, PHD student
Phone +40727786221
Email orzanrares@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Endoscopic ultrasound with fine needle biopsy
Patients with unresectable bile duct tumors will be investigated by either CH-EUS with FNA or conventional EUS with FNA

Locations
Country Name City State
Romania IRGH "O. Fodor" Cluj-Napoca Cluj

Sponsors (1)
Lead Sponsor Collaborator
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Country where clinical trial is conducted

Romania, 

Outcome
Type Measure Description Time frame Safety issue
Primary CH-EUS FNA has higher diagnostic accuracy for bile tuct tumors 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. one week
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