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

NCT06612931 | Completed DMC

• 1 other identifier: 2022108
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The diagnostic accuracy

  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 Outcomes (3)

• the diagnostic sensitivity

  6 months

• The diagnostic specificity

  6 months

• Severe adverse events rates

  6 months

Study Arms (2)

CMB

EXPERIMENTAL

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

BCA

ACTIVE COMPARATOR

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

Interventions

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.

CMB

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.

BCA

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Xijing Hospital of Digestive Diseases: collaborator
• Eastern Hepatobiliary Surgery Hospital: collaborator

Study Sites (1)

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

Shanghai, China, 201620, China

Location

Study Officials

• Baiwen Li, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Gastrointestinal Endoscopy Center

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 25, 2024
• Study Start: April 1, 2023
• Primary Completion: July 20, 2024
• Study Completion: August 16, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-08

Locations

CN (1)