CH-EUS in Diagnosis of Inoperable Bile Duct Tumors

NCT ID: NCT05418543

Last Updated: 2022-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-12-30

Brief Summary

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

Detailed Description

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Conditions

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Inoperable Disease Bile Duct Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EUS-FNA

Group Type EXPERIMENTAL

Endoscopic ultrasound with fine needle biopsy

Intervention Type PROCEDURE

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

CH-EUS-FNA

Group Type EXPERIMENTAL

Endoscopic ultrasound with fine needle biopsy

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Rares-Ilie Orzan

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrada Seicean, Professor

Role: STUDY_DIRECTOR

[email protected]

Locations

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IRGH "O. Fodor"

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Rares-Ilie Orzan, PHD student

Role: CONTACT

+40727786221

Facility Contacts

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Rares Orzan, PHD student

Role: primary

+40727786221

Other Identifiers

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1509/03.02.2022

Identifier Type: -

Identifier Source: org_study_id

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