Comparison of Dual-lumen Catheter-guided Mini-forceps Biopsy and Brush Cytology with Vacuum Aspiration in Suspicious Biliary Strictures

Shanghai Jiao Tong University

Status: Completed

Conditions: Biliary Strictures; Endoscopic Retrograde Cholangiopancreatography (ERCP); Miniforceps Biopsy; Brush Cytology

Treatments: Procedure: Dual-lumen catheter-guided mini-forceps biopsy is performed first; Procedure: Biliary brush cytology with vacuum aspiration is performed first

Study type: Interventional

Funder types: Other

Identifiers

NCT06612931

2022108

Details and patient eligibility

About

In this randomized crossover trial involving patients with indeterminate biliary strictures, we aimed to compare the diagnostic performance of the dual-lumen catheter-guided miniforceps biopsy (CMB) device with that of brush cytology under aspiration (BCA).

Enrollment: 112 patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged between 18-88 years old.
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
• Biliary obstructive symptoms,or indeterminate biliary stricture suspected to be intrinsic based on prior imaging.

Exclusion criteria

• Any contraindications to ERCP.
• Severe cardiopulmonary disease or coagulopathy.
• Biliary strictures caused by extrinsic compression.
• Unwillingness or inability to provide consent.
• Pregnant or breastfeeding women.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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112 participants in 2 patient groups

CMB

Experimental group

Description:

In ERCP procedures, catheter-guided mini-forceps biopsy (CMB) is performed before biliary brush cytology with vacuum aspiration (BCA).

Treatment:

Procedure: Dual-lumen catheter-guided mini-forceps biopsy is performed first

BCA

Active Comparator group

Description:

In ERCP procedures, biliary brush cytology with vacuum aspiration (BCA) is performed before dilation catheter-guided mini-forceps biopsy (CMB).

Treatment:

Procedure: Biliary brush cytology with vacuum aspiration is performed first