An interventional study of Biliary brushing with the RX Cytology brush, Boston Scientific and Biliary brushing with the Infinity® brush, US Endoscopy in Biliary Stricture and Jaundice, Obstructive, sponsored by Société Française d'Endoscopie Digestive. Completed at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-06-21.
Sponsored by Société Française d'Endoscopie Digestive · Not applicable, Interventional, and Diagnostic
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
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
Secondary objective (s):
This study concerns adult subjects with stenosis of the main bile duct (common bile duct or common hepatic duct).
ENDOSCOPIC PROCEDURE
Biliary brushing successively with the 2 brushes in the order designated by randomization:
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
62 studies on the registry are indexed under Jaundice, Obstructive; 15 are open to participants now.
This study's enrollment of 51 is below the median of 75 across 40 interventional studies indexed under Jaundice, Obstructive.
Browse Jaundice, Obstructive studies →Société Française d'Endoscopie Digestive is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: Biliary brushing with the RX Cytology brush, Boston Scientific · Device: Biliary brushing with the Infinity® brush, US Endoscopy
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
Device: Biliary brushing with the RX Cytology brush, Boston Scientific · Device: Biliary brushing with the Infinity® brush, US Endoscopy
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 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)
Sensibility for adenocarcinoma
Rate of positive diagnosis of biliary brushing in case of cholangiocarcinoma stenosis
Time frame: 8 days to 1 year (if negative)
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
Time frame: 8 days
False negative
Negative brushing for a final diagnosis of cholangiocarcinoma
Time frame: 1 year
Predictive Negative Value
probability that patients with a negative brushing truly don't have cholangiocarcinoma
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 1 day
Plan to share: No
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Ran from Jul 2020 to primary completion in Mar 2022, 20 months.
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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Société Française d'Endoscopie Digestive