Biliary StrictureBIBNCT04251013
Multicenter RCT for BIliary Brushing: RX Cytology, BOSTON vs. Infinity®, US Endoscopy
A study testing Biliary brushing with the RX Cytology brush, Boston Scientific and Biliary brushing with the Infinity® brush, US Endoscopy in people with Biliary Stricture and Jaundice, Obstructive, run by Société Française d'Endoscopie Digestive at 1 site in France.
Trial summary
The aim of this prospective national multicenter randomized study is to compare, during an ERCP for VBP stenosis, the sensitivity of two biliary brushes: the INFINITY® vs the RX Cytology Brush® The main objective is the comparison of the rates of positive diagnosis of biliary brushing in cases of adenocarcinoma… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Biliary Stricture, Jaundice, Obstructive
- What is being tested?
- Biliary brushing with the RX Cytology brush, Boston Scientific and Biliary brushing with the Infinity® brush, US Endoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 1 Mar 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient admitted to one of the ERCP investigation centers with brushing and drainage for VBP stenosis (proximal or distal) during the study period
- Patient whose age is greater than or equal to 18 years and less than 90 years
- Patient ASA 1, ASA 2, ASA 3
- Lack of participation in another clinical study
- Signed informed consent
Who cannot join
- Patients admitted for ERCP for jaundice by lithiasic obstruction
- Patient under 18 or over 90
- Patient ASA 4, ASA 5
- Pregnant woman
- Patient (s) with coagulation abnormalities preventing puncture: TP <50%, Platelets <50,000 / mm3, effective anti-coagulation in progress, clopidogrel in progress
- Surgical setup (Billroth II, Roux en Y) preventing endoscopic access to the papilla
- Patient unable to give personal consent
- Lack of signed informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter RCT Comparing Two Brushes of Different Diameters for Biliary Stenosis: RX Cytology Brush, BOSTON vs. Infinity® Brush, US Endoscopy. BIB Study (BIliary Brushing)
The aim of this prospective national multicenter randomized study is to compare, during an ERCP for VBP stenosis, the sensitivity of two biliary brushes: the INFINITY® vs the RX Cytology Brush® The main objective is the comparison of the rates of positive diagnosis of biliary brushing in cases of adenocarcinoma stenosis The total number of subjects required: 50 (25 patients per group) Duration of the inclusion period: 2 years Duration of participation for each subject: from 7 days to 12 months (in case of negative initial withdrawal) Total duration of the study: 3 years
Read the detailed description
The aim of this study is to compare, during an ERCP for VBP stenosis, the sensitivity of two biliary brushes: the INFINITY® vs the RX Cytology Brush®
OBJECTIVES
- Main objective: Comparison of the rates of positive diagnosis of biliary brushing in cases of adenocarcinoma stenosis
- Secondary objective (s):
- Comparison of the quantification of the cellular material obtained (acellular, weak, or abundant), and the presence of cellular cupboards unhooked by the brush
- Comparison of the 2 brushes false negative rates, and negative predictive value for the diagnosis of adenocarcinoma
- Evaluation of the variation in the profitability of brushing and other sampling techniques (intra-biliary biopsies, puncture, aspiration of bile) according to the presence of a tumor mass syndrome of more than 1 cm.
- Evaluation of the variation in the profitability of brushing and other sampling techniques (intra-biliary biopsies, puncture, aspiration of bile) according to the site of the stenosis (distal vs proximal BPV: common bile duct or intrahepatic duct), with the cost effectiveness
- Technical failure rate of brushing and other samples (intra-biliary biopsies, bile aspiration)
This study concerns adult subjects with stenosis of the main bile duct (common bile duct or common hepatic duct).
ENDOSCOPIC PROCEDURE
- Deep catheterization of the biliary duct (whatever the access technique: by the papilla or by precut) and cross stenosis by the guide wire, then biliary dilation (6 to 8mm)
- Randomization if the inclusion criteria are met
- Biliary brushing successively with the 2 brushes in the order designated by randomization:
- Performing a dozen back and forth movements in the stenosis
- Aspiration, if possible of bile by the catheter of the brush for cytological analysis
- The contents of the brush will be spread over 3 blades (numbered) then sectioned and placed in cytolit with the contents of the tubing of the brush flushed with a few cc of cytolit. Each brush in a numbered pot. Blades 1,2 and 3 +/- bile 1 joined to pot n ° 1; blades 4,5 and 6 +/- bile 2 joined to pot 2
- In the event of technical failure (impossibility of accessing the stenosis with the first or second brush, impossibility of removing the brush), the patient will be considered to have failed for this brush (absence of pathological material brought back)
All possible sampling methods will also be taken to obtain the anatomopathological diagnosis: intra-biliary biopsies with adult or pediatric forceps, wire-guided or not, biopsy samples guided by choledochoscopy, puncture under endo-ultrasonography, bile aspiration after release of the biliary stent, according to the physician's habits.
EFFECTIVE The total number of subjects required: 50 (25 patients per group) Duration of the inclusion period: 2 years Duration of participation for each subject: from 7 days to 12 months (in case of negative initial withdrawal) Total duration of the study: 3 years
- Conditions
- Biliary Stricture, Jaundice, Obstructive
- Being tested
- Biliary brushing with the RX Cytology brush, Boston Scientific, Biliary brushing with the Infinity® brush, US Endoscopy
- Medical subject headings
- Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biliary brushing with the RX Cytology brush, Boston ScientificDevice
Biliary brushing during ERCP:
- Performing a dozen back and forth movements in the stenosis
- Bile aspiration if possible, by the catheter of the brush for cytological analysis
- The contents of the brush will be spread over 3 blades (numbered) then sectioned and placed in cytolit with the contents of the tubing of the brush flushed with a few cc of cytolit. Each brush in a numbered pot. Blades 1,2 and 3 +/- bile 1 joined to pot n ° 1; blades 4,5 and 6 +/- bile 2 joined to pot 2
- In the event of technical failure (impossibility of accessing the stenosis with the first or second brush, impossibility of removing the brush), the patient will be considered to have failed for this brush (absence of pathological material brought back)
Biliary brushing with the Infinity® brush, US EndoscopyDevice
Biliary brushing during ERCP:
- Performing a dozen back and forth movements in the stenosis
- Bile aspiration if possible, by the catheter of the brush for cytological analysis
- The contents of the brush will be spread over 3 blades (numbered) then sectioned and placed in cytolit with the contents of the tubing of the brush flushed with a few cc of cytolit. Each brush in a numbered pot. Blades 1,2 and 3 +/- bile 1 joined to pot n ° 1; blades 4,5 and 6 +/- bile 2 joined to pot 2
- In the event of technical failure (impossibility of accessing the stenosis with the first or second brush, impossibility of removing the brush), the patient will be considered to have failed for this brush (absence of pathological material brought back)
| Study group | Role | What they receive |
|---|---|---|
| Group A: RX Cytology brush, Boston Scientific FIRST | Active comparator | A first biliary brushing will be carried out during ERCP using a standard brush RX Cytology Brush, Boston Scientific, then a second brushing will be carried out using a brush INFINITY®, US Endoscopy Receives: Device: Biliary brushing with the RX Cytology brush, Boston Scientific; Device: Biliary brushing with the Infinity® brush, US Endoscopy |
| Group B: Infinity®, US Endoscopy FIRST | Active comparator | A first biliary brushing will be carried out during ERCP using an INFINITY® brush, US Endoscopy then a second brushing will be carried out using standard RX Cytology Brush, Boston Scientific Receives: Device: Biliary brushing with the RX Cytology brush, Boston Scientific; Device: Biliary brushing with the Infinity® brush, US Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility for adenocarcinoma
Rate of positive diagnosis of biliary brushing in case of cholangiocarcinoma stenosis
Measured: 8 days to 1 year (if negative)
Secondary outcomes (7)
Sample abundance
Quantification of the cellular material obtained (acellular, weak, or abundant), presence of cellular cupboards unhooked by the brush or average number of cells per field
Measured: 8 days
False negative
Negative brushing for a final diagnosis of cholangiocarcinoma
Measured: 1 year
Predictive Negative Value
probability that patients with a negative brushing truly don't have cholangiocarcinoma
Measured: 1 year
Feasibility of the 2 brushes: Analog visual scale
Analog visual scale: Feasibility scale (0 to 10, 0 for Extremely difficult to perform and 10 for very easy to perform)
Measured: 1 day
Feasibility of the intra-biliary biopsies: Analog visual scale
Analog visual scale: Feasibility scale (0 to 10, 0 for Extremely difficult to perform and 10 for very easy to perform)
Measured: 1 day
Feasibility of bile aspiration: Analog visual scale
Analog visual scale: Feasibility scale (0 to 10, 0 for Extremely difficult to perform and 10 for very easy to perform)
Measured: 1 day
Feasibility of stenosis puncture under ultrasonography: Analog visual scale
Analog visual scale: Feasibility scale (0 to 10, 0 for Extremely difficult to perform and 10 for very easy to perform)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start1 Jul 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary StrictureStudies 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
- Model description
- National prospective multicenter RCT
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KARSENTI, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251013
- Sponsor's protocol ID
- BIB study
- Acronym
- BIB
- Status last verified
- Jun 2022
- First submitted
- 25 Jan 2020
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karsenti D, Privat J, Charissoux A, Perrot B, Leblanc S, Chaput U, Boytchev I, Levy J, Schaefer M, Bourgaux JF, Valats JC, Coron E, Moreno-Garcia M, Vanbiervliet G, Rahmi G, Robles EP, Wallenhorst T. Multicenter randomized trial comparing diagnostic sensitivity and cellular abundance with aggressive versus standard biliary brushing for bile duct stenosis without mass syndrome. Endoscopy. 2023 Sep;55(9):796-803. doi: 10.1055/a-2041-7687. Epub 2023 Feb 27.
PubMed 36849106
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter RCT Comparing Two Brushes of Different Diameters for Biliary Stenosis: RX Cytology Brush, BOSTON vs. Infinity® Brush, US Endoscopy. BIB Study (BIliary Brushing)
- ClinicalTrials.gov ID
- NCT04251013
- Acronym / sponsor ID
- BIB / BIB study
- Conditions
- Biliary Stricture, Jaundice, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Société Française d'Endoscopie DigestiveUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 31 Jan 2020 (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 aim of this prospective national multicenter randomized study is to compare, during an ERCP for VBP stenosis, the sensitivity of two biliary brushes: the INFINITY® vs the RX Cytology Brush® The main objective is the comparison of the rates of positive diagnosis of biliary brushing in cases of adenocarcinoma stenosis The total number of subjects required: 50 (25 patients per group) Duration of the inclusion period: 2 years Duration of participation for each subject: from 7 days to 12 months (in case of negative initial withdrawal) Total duration of the study: 3 years
Detailed description
The aim of this study is to compare, during an ERCP for VBP stenosis, the sensitivity of two biliary brushes: the INFINITY® vs the RX Cytology Brush®
OBJECTIVES
- Main objective: Comparison of the rates of positive diagnosis of biliary brushing in cases of adenocarcinoma stenosis
- Secondary objective (s):
- Comparison of the quantification of the cellular material obtained (acellular, weak, or abundant), and the presence of cellular cupboards unhooked by the brush
- Comparison of the 2 brushes false negative rates, and negative predictive value for the diagnosis of adenocarcinoma
- Evaluation of the variation in the profitability of brushing and other sampling techniques (intra-biliary biopsies, puncture, aspiration of bile) according to the presence of a tumor mass syndrome of more than 1 cm.
- Evaluation of the variation in the profitability of brushing and other sampling techniques (intra-biliary biopsies, puncture, aspiration of bile) according to the site of the stenosis (distal vs proximal BPV: common bile duct or intrahepatic duct), with the cost effectiveness
- Technical failure rate of brushing and other samples (intra-biliary biopsies, bile aspiration)
This study concerns adult subjects with stenosis of the main bile duct (common bile duct or common hepatic duct).
ENDOSCOPIC PROCEDURE
- Deep catheterization of the biliary duct (whatever the access technique: by the papilla or by precut) and cross stenosis by the guide wire, then biliary dilation (6 to 8mm)
- Randomization if the inclusion criteria are met
- Biliary brushing successively with the 2 brushes in the order designated by randomization:
- Performing a dozen back and forth movements in the stenosis
- Aspiration, if possible of bile by the catheter of the brush for cytological analysis
- The contents of the brush will be spread over 3 blades (numbered) then sectioned and placed in cytolit with the contents of the tubing of the brush flushed with a few cc of cytolit. Each brush in a numbered pot. Blades 1,2 and 3 +/- bile 1 joined to pot n ° 1; blades 4,5 and 6 +/- bile 2 joined to pot 2
- In the event of technical failure (impossibility of accessing the stenosis with the first or second brush, impossibility of removing the brush), the patient will be considered to have failed for this brush (absence of pathological material brought back)
All possible sampling methods will also be taken to obtain the anatomopathological diagnosis: intra-biliary biopsies with adult or pediatric forceps, wire-guided or not, biopsy samples guided by choledochoscopy, puncture under endo-ultrasonography, bile aspiration after release of the biliary stent, according to the physician's habits.
EFFECTIVE The total number of subjects required: 50 (25 patients per group) Duration of the inclusion period: 2 years Duration of participation for each subject: from 7 days to 12 months (in case of negative initial withdrawal) Total duration of the study: 3 years
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- National prospective multicenter RCT
| Arm | Type | Receives |
|---|---|---|
| Group A: RX Cytology brush, Boston Scientific FIRST | Active comparator | Device: Biliary brushing with the RX Cytology brush, Boston Scientific, Device: Biliary brushing with the Infinity® brush, US EndoscopyA first biliary brushing will be carried out during ERCP using a standard brush RX Cytology Brush, Boston Scientific, then a second brushing will be carried out using a brush INFINITY®, US Endoscopy |
| Group B: Infinity®, US Endoscopy FIRST | Active comparator | Device: Biliary brushing with the RX Cytology brush, Boston Scientific, Device: Biliary brushing with the Infinity® brush, US EndoscopyA first biliary brushing will be carried out during ERCP using an INFINITY® brush, US Endoscopy then a second brushing will be carried out using standard RX Cytology Brush, Boston Scientific |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient admitted to one of the ERCP investigation centers with brushing and drainage for VBP stenosis (proximal or distal) during the study period
- Patient whose age is greater than or equal to 18 years and less than 90 years
- Patient ASA 1, ASA 2, ASA 3
- Lack of participation in another clinical study
- Signed informed consent
Key exclusion criteria (8 listed)
- Patients admitted for ERCP for jaundice by lithiasic obstruction
- Patient under 18 or over 90
- Patient ASA 4, ASA 5
- Pregnant woman
- Patient (s) with coagulation abnormalities preventing puncture: TP <50%, Platelets <50,000 / mm3, effective anti-coagulation in progress, clopidogrel in progress
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 |
|---|---|---|
| Biliary brushing with the RX Cytology brush, Boston ScientificBiliary brushing during ERCP: * Performing a dozen back and forth movements in the stenosis * Bile aspiration if possible, by the catheter of the brush for cytological analysis * The contents of the brush will be spread over 3 blades (numbered) then sectioned and placed in cytolit with the contents of the tubing of the brush flushed with a few cc of cytolit. Each brush in a numbered pot. Blades 1,2 and 3 +/- bile 1 joined to pot n ° 1; blades 4,5 and 6 +/- bile 2 joined to pot 2 * In the event of technical failure (impossibility of accessing the stenosis with the first or second brush, impossibility of removing the brush), the patient will be considered to have failed for this brush (absence of pathological material brought back) | Device | Group A: RX Cytology brush, Boston Scientific FIRST, Group B: Infinity®, US Endoscopy FIRST |
| Biliary brushing with the Infinity® brush, US EndoscopyBiliary brushing during ERCP: * Performing a dozen back and forth movements in the stenosis * Bile aspiration if possible, by the catheter of the brush for cytological analysis * The contents of the brush will be spread over 3 blades (numbered) then sectioned and placed in cytolit with the contents of the tubing of the brush flushed with a few cc of cytolit. Each brush in a numbered pot. Blades 1,2 and 3 +/- bile 1 joined to pot n ° 1; blades 4,5 and 6 +/- bile 2 joined to pot 2 * In the event of technical failure (impossibility of accessing the stenosis with the first or second brush, impossibility of removing the brush), the patient will be considered to have failed for this brush (absence of pathological material brought back) | Device | Group A: RX Cytology brush, Boston Scientific FIRST, Group B: Infinity®, US Endoscopy FIRST |
Primary outcome
Sensibility for adenocarcinoma
Time frame: 8 days to 1 year (if negative)
Rate of positive diagnosis of biliary brushing in case of cholangiocarcinoma stenosis
7 secondary outcomes
Sample abundance
Time frame: 8 days
False negative
Time frame: 1 year
Predictive Negative Value
Time frame: 1 year
Feasibility of the 2 brushes: Analog visual scale
Time frame: 1 day
Feasibility of the intra-biliary biopsies: Analog visual scale
Time frame: 1 day
Feasibility of bile aspiration: Analog visual scale
Time frame: 1 day
Feasibility of stenosis puncture under ultrasonography: Analog visual scale
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Derived from this study: PubMed 36849106Karsenti D, Privat J, Charissoux A, Perrot B, Leblanc S, Chaput U, Boytchev I, Levy J, Schaefer M, Bourgaux JF, Valats JC, Coron E, Moreno-Garcia M, Vanbiervliet G, Rahmi G, Robles EP, Wallenhorst T. Multicenter randomized trial comparing diagnostic sensitivity and cellular abundance with aggressive versus standard biliary brushing for bile duct stenosis without mass syndrome. Endoscopy. 2023 Sep;55(9):796-803. doi: 10.1055/a-2041-7687. Epub 2023 Feb 27.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biliary brushing with the RX Cytology brush, Boston Scientific and Biliary brushing with the Infinity® brush, US Endoscopy in people with Biliary Stricture and Jaundice, Obstructive, run by Société Française d'Endoscopie Digestive at 1 site in France.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 21 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensibility for adenocarcinoma (time frame: 8 days to 1 year (if negative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04251013, which also lists 1 linked publication.
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 Jun 2022.