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

NCT ID: NCT06612931

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-08-16

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CMB

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

In ERCP procedures, catheter-guided mini-forceps biopsy is performed before biliary brush cytology.

BCA

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

Group Type ACTIVE_COMPARATOR

Biliary brush cytology with vacuum aspiration is performed first

Intervention Type PROCEDURE

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

Interventions

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

In ERCP procedures, catheter-guided mini-forceps biopsy is performed before biliary brush cytology.

Intervention Type PROCEDURE

Biliary brush cytology with vacuum aspiration is performed first

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role collaborator

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Baiwen Li

Director of the Gastrointestinal Endoscopy Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Baiwen Li, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine

Locations

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Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China, China

Site Status

Countries

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China

Other Identifiers

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2022108

Identifier Type: -

Identifier Source: org_study_id

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