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

NCT03307382 | Active Not Recruiting FDA Device

• 1 other identifier: SOC for biliary strictrure
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Biliary stricture, cholangioscopy

Outcome Measures

Primary Outcomes (1)

• sensitivity, specificity, and accuracy of the digital SOC during ERCP in the diagnosis of malignant and benign biliary strictures.

  To assess the sensitivity, specificity, and accuracy of digital SOC in the diagnosis of biliary strictures

  Till a diagnosis of a malignant stricture is made, or follow up period of at least 6 months for presumed benign stricture

Study Arms (1)

SpyGlass DS Cholangioscopy

EXPERIMENTAL

ERCP with cholangiogram will be performed to assess the common bile duct (CBD) and intrahepatic ducts (IHD) for presence of a stricture. Once a biliary stricture is confirmed on cholangiogram during ERCP, SpyGlass DS Cholangioscopy would be performed. 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. Endoscopic stenting will be performed in standard fashion for biliary drainage to relieve the obstructive jaundice.

Device: SpyGlass DS Cholangioscopy

Interventions

SpyGlass DS Cholangioscopy DEVICE

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.

SpyGlass DS Cholangioscopy

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Patients presenting with obstructive jaundice with clinical suspicion for a biliary stricture based on imaging findings or during ERCP
• Written informed consent available

You may not qualify if:

• Contraindications for endoscopy due to comorbidities
• Unable to provide written informed consent
• Patients with clinical evidence of ongoing cholangitis precluding a safe cholangioscopy procedure
• Pregnant patients
• Moribund patients from terminal illnesses

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Location

Study Officials

• Raymond S Tang, MD

  Prince of Wales Hospital, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professional Consultant

Model Details: Cohort study

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 11, 2017
• Study Start: December 15, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)