Multicenter RCT for BIliary Brushing: RX Cytology, BOSTON vs. Infinity®, US Endoscopy

NCT04251013 | Completed

• 1 other identifier: BIB study
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Biliary Stricture; Jaundice, Obstructive

Outcome Measures

Primary Outcomes (1)

• Sensibility for adenocarcinoma

  Rate of positive diagnosis of biliary brushing in case of cholangiocarcinoma stenosis

  8 days to 1 year (if negative)

Secondary Outcomes (7)

• Sample abundance

  8 days

• False negative

  1 year

• Predictive Negative Value

  1 year

• Feasibility of the 2 brushes: Analog visual scale

  1 day

• Feasibility of the intra-biliary biopsies: Analog visual scale

  1 day

Study Arms (2)

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

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

Device: Biliary brushing with the RX Cytology brush, Boston Scientific; Device: Biliary brushing with the Infinity® brush, US Endoscopy

Interventions

Biliary brushing with the RX Cytology brush, Boston Scientific DEVICE

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)

Group A: RX Cytology brush, Boston Scientific FIRST; Group B: Infinity®, US Endoscopy FIRST

Biliary brushing with the Infinity® brush, US Endoscopy DEVICE

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)

Group A: RX Cytology brush, Boston Scientific FIRST; Group B: Infinity®, US Endoscopy FIRST

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead

Study Sites (1)

Clinique Paris Bercy

Charenton-le-Pont, F-94220, France

Location

Related Publications (1)

• 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.

  PMID: 36849106 DERIVED

MeSH Terms

Conditions

Jaundice, Obstructive

Condition Hierarchy (Ancestors)

Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: National prospective multicenter RCT

Study Record Dates

• First Submitted: January 25, 2020
• First Posted: January 31, 2020
• Study Start: July 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)