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CH-EUS in Diagnosis of Inoperable Bile Duct Tumors

Primary Purpose

Inoperable Disease, Bile Duct Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Romania

Study Type

Interventional

Intervention

Endoscopic ultrasound with fine needle biopsy

About this trial

This is an interventional diagnostic trial for Inoperable Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

IRGH "O. Fodor"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

EUS-FNA

CH-EUS-FNA

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05418543

First Posted

June 7, 2022

Last Updated

June 14, 2022

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT05418543

Brief Title

CH-EUS in Diagnosis of Inoperable Bile Duct Tumors

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inoperable Disease, Bile Duct Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EUS-FNA

Arm Type

Experimental

Arm Title

CH-EUS-FNA

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Endoscopic ultrasound with fine needle biopsy

Intervention Description

Patients with unresectable bile duct tumors will be investigated by either CH-EUS with FNA or conventional EUS with FNA

Primary Outcome Measure Information:

Title

CH-EUS FNA has higher diagnostic accuracy for bile tuct tumors

Description

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.

Time Frame

one week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rares-Ilie Orzan, PHD student

Phone

+40727786221

orzanrares@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrada Seicean, Professor

Organizational Affiliation

andradaseicean@gmail.com

Official's Role

Study Director

Facility Information:

Facility Name

IRGH "O. Fodor"

City

Cluj-Napoca

State/Province

Cluj

ZIP/Postal Code

400394

Country

Romania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rares Orzan, PHD student

Phone

+40727786221

orzanrares@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

CH-EUS in Diagnosis of Inoperable Bile Duct Tumors

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