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

September 23, 2024 updated by: Baiwen Li, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Comparison of Dual-lumen Catheter-guided Mini-forceps Biopsy and Brush Cytology with Vacuum Aspiration in Suspicious Biliary Strictures: a Multicenter, Randomized, Crossover Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 201620
        • Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CMB
In ERCP procedures, catheter-guided mini-forceps biopsy (CMB) is performed before biliary brush cytology with vacuum aspiration (BCA).
Procedure: Dual-lumen catheter-guided mini-forceps biopsy is performed first
In ERCP procedures, catheter-guided mini-forceps biopsy is performed before biliary brush cytology.
Active Comparator: BCA
In ERCP procedures, biliary brush cytology with vacuum aspiration (BCA) is performed before dilation catheter-guided mini-forceps biopsy (CMB).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic accuracy
Time Frame: 6 months
The accuracy of dual-lumen catheter-guided miniforceps biopsy (CMB) and brush cytology with vacuum aspiration (BCA) in the diagnosis of biliary strictures.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the diagnostic sensitivity
Time Frame: 6 months
The diagnostic sensitivity of dual-lumen catheter-guided mini-forceps biopsy and brush cytology with vacuum aspiration to the suspicious biliary strictures.
6 months
The diagnostic specificity
Time Frame: 6 months
The diagnostic specificity of dual-lumen catheter-guided mini-forceps biopsy and brush cytology with vacuum aspiration to the suspicious biliary strictures.
6 months
Severe adverse events rates
Time Frame: 6 months
The incidence of adverse events, namely, post-ERCP pancreatitis, gastrointestinal perforation, and bleeding were compared.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Xijing Hospital of Digestive Diseases
Eastern Hepatobiliary Surgery Hospital

Investigators

  • Principal Investigator: Baiwen Li, Ph.D., Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

July 20, 2024

Study Completion (Actual)

August 16, 2024

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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