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Single-operator Digital Cholangioscopy for the Diagnosis of Malignant and Benign Biliary Strictures

NCT03307382 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-19

No results posted yet for this study

Summary

Differentiation between malignant and benign biliary strictures can be challenging. Accurate differentiation of malignant biliary strictures from benign ones is crucial to guide management decisions.

While conventional tissue acquisition techniques such as brush cytology or intraductal biopsy of the biliary stricture is often performed during ERCP for tissue diagnosis, their sensitivities are suboptimal. The average sensitivities for brush cytology and intraductal biopsy were reported to be \~ 59% and \~ 63% respectively.

When the cause of a biliary stricture remains unclear despite conventional ERCP techniques for diagnosis, cholangioscopy is often performed during ERCP to clarify the diagnosis. This allows an endoscopist to obtain a visual impression (VI) and to perform targeted biopsy under direct visualization of the biliary stricture.

Recently, a digital SOC system (SpyGlass Digital System (SpyGlass DS), Boston Scientific, USA) has become available and has the potential to further improve the diagnosis of malignant and benign biliary strictures. The utility of this digital SOC in the evaluation of biliary strictures has not been well studied. We propose this study to evaluate the utility of the digital SOC during ERCP in the diagnosis of malignant and benign biliary strictures.

Conditions

  • Biliary Stricture

Interventions

DEVICE

SpyGlass DS Cholangioscopy

SpyGlass DS Cholangioscopy includes a 10 French diameter single use digital cholangioscope and a light source with the digital sensor. During ERCP with cholangioscopic exam, the cholangioscope would be first inserted through the working channel of the duodenoscope and subsequently passed into the bile duct for direct visualization of the bile duct mucosa. The visual impression (VI) of the biliary stricture will be assessed. Tissue acquisition of the biliary stricture will be performed by cholangioscopy directed biopsy (CDBx), and conventional brush cytology with or without intraductal biopsy.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Raymond S Tang, MD · Prince of Wales Hospital, The Chinese University of Hong Kong

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-15
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • Hong Kong

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 NCT03307382 on ClinicalTrials.gov