CH-EUS in Diagnosis of Inoperable Bile Duct Tumors
Sponsor
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor (Other)
Overall Status
Recruiting
CT.gov ID
NCT05418543
Collaborator
(none)
40
1
2
11.9
3.4
Study Details
Study Description
Brief Summary
VALIDATION OF THE SUPERIORITY OF CONTRAST ENHANCED ENDOSCOPY TO STANDARD ENDOSCOPY IN THE DIAGNOSIS OF BILE DUCT TUMORS
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Contrast-enhanced Endoscopic Ultrasound in Diagnosis of Inoperable Bile Duct Tumors
Actual Study Start Date
:
Jan 1, 2022
Anticipated Primary Completion Date
:
Dec 30, 2022
Anticipated Study Completion Date
:
Dec 30, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EUS-FNA
|
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
|
| Experimental: CH-EUS-FNA
|
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
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRGH "O. Fodor" | Cluj-Napoca | Cluj | Romania | 400394 |
Sponsors and Collaborators
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Investigators
- Study Director: Andrada Seicean, Professor, andradaseicean@gmail.com
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Rares-Ilie Orzan,
Doctor,
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
ClinicalTrials.gov Identifier:
NCT05418543
Other Study ID Numbers:
- 1509/03.02.2022
First Posted:
Jun 14, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: