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

NCT06612931 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-09-25

No results posted yet for this study

Summary

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).

Conditions

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

Interventions

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.

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.

Sponsors & Collaborators

  • Xijing Hospital of Digestive Diseases

    collaborator OTHER

  • Eastern Hepatobiliary Surgery Hospital

    collaborator OTHER

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-07-20
Completion
2024-08-16

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06612931 on ClinicalTrials.gov