- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04251013
Multicenter RCT for BIliary Brushing: RX Cytology, BOSTON vs. Infinity®, US Endoscopy (BIB)
Multicenter RCT Comparing Two Brushes of Different Diameters for Biliary Stenosis: RX Cytology Brush, BOSTON vs. Infinity® Brush, US Endoscopy. BIB Study (BIliary Brushing)
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Charenton-le-Pont, France, F-94220
- Clinique Paris Bercy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A: RX Cytology brush, Boston Scientific FIRST
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
|
Biliary brushing during ERCP:
Biliary brushing during ERCP:
|
Active Comparator: Group B: Infinity®, US Endoscopy FIRST
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
|
Biliary brushing during ERCP:
Biliary brushing during ERCP:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensibility for adenocarcinoma
Time Frame: 8 days to 1 year (if negative)
|
Rate of positive diagnosis of biliary brushing in case of cholangiocarcinoma stenosis
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8 days to 1 year (if negative)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sample abundance
Time Frame: 8 days
|
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
|
8 days
|
False negative
Time Frame: 1 year
|
Negative brushing for a final diagnosis of cholangiocarcinoma
|
1 year
|
Predictive Negative Value
Time Frame: 1 year
|
probability that patients with a negative brushing truly don't have cholangiocarcinoma
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1 year
|
Feasibility of the 2 brushes: Analog visual scale
Time Frame: 1 day
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Analog visual scale: Feasibility scale (0 to 10, 0 for Extremely difficult to perform and 10 for very easy to perform)
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1 day
|
Feasibility of the intra-biliary biopsies: Analog visual scale
Time Frame: 1 day
|
Analog visual scale: Feasibility scale (0 to 10, 0 for Extremely difficult to perform and 10 for very easy to perform)
|
1 day
|
Feasibility of bile aspiration: Analog visual scale
Time Frame: 1 day
|
Analog visual scale: Feasibility scale (0 to 10, 0 for Extremely difficult to perform and 10 for very easy to perform)
|
1 day
|
Feasibility of stenosis puncture under ultrasonography: Analog visual scale
Time Frame: 1 day
|
Analog visual scale: Feasibility scale (0 to 10, 0 for Extremely difficult to perform and 10 for very easy to perform)
|
1 day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIB study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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