NCT05418543

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

12 months

First QC Date

June 7, 2022

Last Update Submit

June 14, 2022

Conditions

Inoperable DiseaseBile Duct Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

EUS-FNA

EXPERIMENTAL
Procedure: Endoscopic ultrasound with fine needle biopsy

CH-EUS-FNA

EXPERIMENTAL
Procedure: Endoscopic ultrasound with fine needle biopsy

Interventions

Endoscopic ultrasound with fine needle biopsyPROCEDURE

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

CH-EUS-FNAEUS-FNA

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bile duct tumor diagnosed at endoscopic US, CT scan or MRI
  • INR\<1.5; platelets \> 50.000
  • written consent form

You may not qualify if:

  • INR\>1.5; platelets \< 50.000
  • duodenal invasion or stenosis
  • patients denial
  • previous treatment for hepato-biliary tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRGH "O. Fodor"

Cluj-Napoca, Cluj, 400394, Romania

RECRUITING

MeSH Terms

Conditions

Bile Duct Neoplasms

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativePuncturesInvestigative Techniques

Study Officials

  • Andrada Seicean, Professor

    andradaseicean@gmail.com

    STUDY DIRECTOR

Central Study Contacts

Rares-Ilie Orzan, PHD student

CONTACT

+40727786221orzanrares@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 7, 2022

First Posted

June 14, 2022

Study Start

January 1, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

June 15, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)