CH-EUS in Diagnosis of Inoperable Bile Duct Tumors

June 14, 2022 updated by: Rares-Ilie Orzan, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400394
        • Recruiting
        • IRGH "O. Fodor"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CH-EUS FNA has higher diagnostic accuracy for bile tuct tumors
Time Frame: 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.
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Director: Andrada Seicean, Professor, andradaseicean@gmail.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2022

Primary Completion (ANTICIPATED)

December 30, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 9, 2022

First Posted (ACTUAL)

June 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1509/03.02.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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