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Completed

NCT Number: NCT06612931

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

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).

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Key information

Conditions

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

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, China, 201620

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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

Biliary brush cytology with vacuum aspiration is performed first

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Severe adverse events rates

    Time frame: 6 months

    The incidence of adverse events, namely, post-ERCP pancreatitis, gastrointestinal perforation, and bleeding were compared.

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Eastern Hepatobiliary Surgery Hospital
  • Xijing Hospital of Digestive Diseases

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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