Inoperable DiseaseNCT05418543
CH-EUS in Diagnosis of Inoperable Bile Duct Tumors
A study testing Endoscopic ultrasound with fine needle biopsy in people with Inoperable Disease and Bile Duct Cancer, run by Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor at 1 site in Romania.
Trial summary
VALIDATION OF THE SUPERIORITY OF CONTRAST ENHANCED ENDOSCOPY TO STANDARD ENDOSCOPY IN THE DIAGNOSIS OF BILE DUCT TUMORS Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Inoperable Disease, Bile Duct Cancer
- What is being tested?
- Endoscopic ultrasound with fine needle biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bile duct tumor diagnosed at endoscopic US, CT scan or MRI
- INR<1.5; platelets > 50.000
- written consent form
Who cannot join
- INR>1.5; platelets < 50.000
- duodenal invasion or stenosis
- patients denial
- previous treatment for hepato-biliary tumors
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
IRGH "O. Fodor"
Cluj-Napoca, Cluj, 400394
Rares Orzan, PHD student, +40727786221, orzanrares@gmail.com
About this study
Official title: 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
- Conditions
- Inoperable Disease, Bile Duct Cancer
- Being tested
- Endoscopic ultrasound with fine needle biopsy
- Medical subject headings
- Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound with fine needle biopsyProcedure or surgery
Patients with unresectable bile duct tumors will be investigated by either CH-EUS with FNA or conventional EUS with FNA
| Study group | Role | What they receive |
|---|---|---|
| EUS-FNA | Experimental | Not described Receives: Procedure: Endoscopic ultrasound with fine needle biopsy |
| CH-EUS-FNA | Experimental | Not described Receives: Procedure: Endoscopic ultrasound with fine needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Jan 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inoperable DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rares-Ilie Orzan, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Investigators
- Andrada Seicean, Professor, Study director, andradaseicean@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418543
- Sponsor's protocol ID
- 1509/03.02.2022
- Status last verified
- Jun 2022
- First submitted
- 7 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced Endoscopic Ultrasound in Diagnosis of Inoperable Bile Duct Tumors
- ClinicalTrials.gov ID
- NCT05418543
- Acronym / sponsor ID
- 1509/03.02.2022
- Conditions
- Inoperable Disease, Bile Duct Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian FodorUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
VALIDATION OF THE SUPERIORITY OF CONTRAST ENHANCED ENDOSCOPY TO STANDARD ENDOSCOPY IN THE DIAGNOSIS OF BILE DUCT TUMORS
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-FNA | Experimental | Procedure: Endoscopic ultrasound with fine needle biopsy |
| CH-EUS-FNA | Experimental | Procedure: Endoscopic ultrasound with fine needle biopsy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bile duct tumor diagnosed at endoscopic US, CT scan or MRI
- INR<1.5; platelets > 50.000
- written consent form
Key exclusion criteria (4 listed)
- INR>1.5; platelets < 50.000
- duodenal invasion or stenosis
- patients denial
- previous treatment for hepato-biliary tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ultrasound with fine needle biopsyPatients with unresectable bile duct tumors will be investigated by either CH-EUS with FNA or conventional EUS with FNA | Procedure or surgery | CH-EUS-FNA, EUS-FNA |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrada Seicean, Professor study director
andradaseicean@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound with fine needle biopsy in people with Inoperable Disease and Bile Duct Cancer, run by Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rares-Ilie Orzan, PHD student (+40727786221, orzanrares@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CH-EUS FNA has higher diagnostic accuracy for bile tuct tumors (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.