Biliary Tract CarcinomaBICRYOBNCT06047990
Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction
A study testing Cryobiopsy catheter in people with Biliary Tract Carcinoma and Biliary Obstruction, run by Brno University Hospital at 1 site in Czechia.
Trial summary
The rationale of the study is to explore the safety and efficacy of percutaneously performed endobiliary cryobiopsy in patiens with histologically unverified biliary stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Carcinoma, Biliary Obstruction
- What is being tested?
- Cryobiopsy catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2023to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- biliary stenosis of unknown etiology
- unsuccessful or unfeasable ERCP
- indicated percutaneous transhepatic drainage
Who cannot join
- histologically verified biliary stenosis
- INR ≥ 1,5
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Brno University Hospital
Brno, 62500
Tomáš Andrašina, MD, +420777674769, andrasina.tomas@fnbrno.cz
About this study
The rationale of the study is to explore the safety and efficacy of percutaneously performed endobiliary cryobiopsy in patiens with histologically unverified biliary stenosis.
Read the detailed description
In patients with malignant biliary stenosis in whom endoscopic retrograde cholangiography (ERCP) is not feasible , percutaneous transhepatic drainage (PTD) is indicated. Biopsy is required for further management of the patient. In patients unsuitable for biopsy under CT or endoscopic guidance, samples can be collected endobiliary by PTD. The biopsy vie PTD can be sampled either at the initial drainage using disposable 5.2F forceps or delayed after 2 or more days using 7.5F endobiliary forceps. An alternative to this procedure is endobiliary sampling by cryobiopsy using 1.1mm, 1.7mm or 2.4mm catheters. To minimize bias, each patient will be sampled both by cryobiopsy and forceps biopsy. The order of cryobiopsy and forceps biopsy will be randomized.
- Conditions
- Biliary Tract Carcinoma, Biliary Obstruction
- Being tested
- Cryobiopsy catheter
- Keywords
- cryobiopsy, biliary obstruction, percutaneous transhepatic drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryobiopsy catheterDevice
Comparison of endobiliary forceps biopsy and cryobiopsy of biliary stenosis during percutaneous transhepatic drainage.
| Study group | Role | What they receive |
|---|---|---|
| Cryobiopsy | Experimental | In randomised patients in experimental arm was initially performed cryobiopsy (3 samples) and cosequently forceps biopsy (6 samples) with 5.2F or 7.5F forceps. Both sampling techniques were performed during one procedure of percutaneous transhepatic drainage under fluoroscopic control. Receives: Device: Cryobiopsy catheter |
| Forceps biopsy | Active comparator | In randomised patients in control arm was initially performed forceps biopsy (6 samples) with 5.2F or 7.5F forceps and cosequently cryobiopsy (3 samples). Both sampling techniques were performed during one procedure of percutaneous transhepatic drainage under fluoroscopic control. Receives: Device: Cryobiopsy catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of biopsy sampling to detect malignancy
Comparison of sensitivity of endobiliary cryobiopsy and forceps biopsy for detection of malignancy.
Measured: up to month 12 or death of the patient
Quality of samples collected by endobiliary cryobiopsy and forceps biopsy - weight
Comparison of weight (in milligrams) of samples collected by endobiliary cryopsy and forceps biopsy. Each sample will be weighed separately and one measurement value will be recorded for each sample.
Measured: up to month 12 or death of the patient
Quality of samples collected by endobiliary cryobiopsy and forceps biopsy - size
Comparison of the size weight (in millimeters) of samples collected by endobiliary cryopsy and forceps biopsy. Each sample will be weighed in two dimensions on slide.
Measured: up to month 12 or death of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jun 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CarcinomaStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomas Andrasina, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047990
- Sponsor's protocol ID
- FNBKRNM0003
- Acronym
- BICRYOB
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction
- ClinicalTrials.gov ID
- NCT06047990
- Acronym / sponsor ID
- BICRYOB / FNBKRNM0003
- Conditions
- Biliary Tract Carcinoma, Biliary Obstruction
- Keywords
- cryobiopsy, biliary obstruction, percutaneous transhepatic drainage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Sep 2023 (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.
The rationale of the study is to explore the safety and efficacy of percutaneously performed endobiliary cryobiopsy in patiens with histologically unverified biliary stenosis.
Detailed description
In patients with malignant biliary stenosis in whom endoscopic retrograde cholangiography (ERCP) is not feasible , percutaneous transhepatic drainage (PTD) is indicated. Biopsy is required for further management of the patient. In patients unsuitable for biopsy under CT or endoscopic guidance, samples can be collected endobiliary by PTD. The biopsy vie PTD can be sampled either at the initial drainage using disposable 5.2F forceps or delayed after 2 or more days using 7.5F endobiliary forceps. An alternative to this procedure is endobiliary sampling by cryobiopsy using 1.1mm, 1.7mm or 2.4mm catheters. To minimize bias, each patient will be sampled both by cryobiopsy and forceps biopsy. The order of cryobiopsy and forceps biopsy will be randomized.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryobiopsy | Experimental | Device: Cryobiopsy catheterIn randomised patients in experimental arm was initially performed cryobiopsy (3 samples) and cosequently forceps biopsy (6 samples) with 5.2F or 7.5F forceps. Both sampling techniques were performed during one procedure of percutaneous transhepatic drainage under fluoroscopic control. |
| Forceps biopsy | Active comparator | Device: Cryobiopsy catheterIn randomised patients in control arm was initially performed forceps biopsy (6 samples) with 5.2F or 7.5F forceps and cosequently cryobiopsy (3 samples). Both sampling techniques were performed during one procedure of percutaneous transhepatic drainage under fluoroscopic control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- biliary stenosis of unknown etiology
- unsuccessful or unfeasable ERCP
- indicated percutaneous transhepatic drainage
Key exclusion criteria (2 listed)
- histologically verified biliary stenosis
- INR ≥ 1,5
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 |
|---|---|---|
| Cryobiopsy catheterComparison of endobiliary forceps biopsy and cryobiopsy of biliary stenosis during percutaneous transhepatic drainage. | Device | Cryobiopsy, Forceps biopsy |
Primary outcome
Sensitivity of biopsy sampling to detect malignancy
Time frame: up to month 12 or death of the patient
Comparison of sensitivity of endobiliary cryobiopsy and forceps biopsy for detection of malignancy.
Quality of samples collected by endobiliary cryobiopsy and forceps biopsy - weight
Time frame: up to month 12 or death of the patient
Comparison of weight (in milligrams) of samples collected by endobiliary cryopsy and forceps biopsy. Each sample will be weighed separately and one measurement value will be recorded for each sample.
Quality of samples collected by endobiliary cryobiopsy and forceps biopsy - size
Time frame: up to month 12 or death of the patient
Comparison of the size weight (in millimeters) of samples collected by endobiliary cryopsy and forceps biopsy. Each sample will be weighed in two dimensions on slide.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryobiopsy catheter in people with Biliary Tract Carcinoma and Biliary Obstruction, run by Brno University Hospital at 1 site in Czechia.
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 2 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 21 Sep 2023. 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 Czechia. 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 Tomáš Andrašina, MD (+420777674769, andrasina.tomas@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of biopsy sampling to detect malignancy (time frame: up to month 12 or death of the patient). The study lists 3 primary outcomes in all. 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 21 Sep 2023.