Multicenter RCT for BIliary Brushing: RX Cytology, BOSTON vs. Infinity®, US Endoscopy
Condition: Biliary Stricture; Jaundice, Obstructive
MeSH terms: Jaundice; Jaundice, Obstructive
Study type: Interventional

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 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
    

Intervention name(s): Biliary brushing with the RX Cytology brush, Boston Scientific; Biliary brushing with the Infinity® brush, US Endoscopy
Intervention type(s): Device; Device
Intervention description(s): 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)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: National prospective multicenter RCT
Masking: None (Open Label)
Primary purpose: Diagnostic