- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03307382
Single-operator Digital Cholangioscopy for the Diagnosis of Malignant and Benign Biliary Strictures
Evaluation of the Utility of Single-operator Digital Cholangioscopy During Endoscopic Retrograde Cholangiopancreatography in the Diagnosis of Malignant and Benign Biliary Strictures
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 a mass lesion involving the bile duct may be observed on imaging such as ultrasound (USG), computed tomography (CT), or magnetic resonance imaging (MRI) in patient presenting with obstructive jaundice, early malignancy of the bile duct may often present with a ductal stricture without an obvious mass on imaging. Diagnosis of early stage malignancy of the bile duct is desirable since the lesion may be amenable to surgical resection of curative intent.
Endoscopic retrograde cholangiopancreatography (ERCP) is an important diagnostic and therapeutic endoscopic technique in patients with obstructive jaundice and a suspected biliary stricture. 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. Cholangioscopy performed during ERCP involves passing a small scope (~ 10 French in size) through the working channel of the ERCP duodenoscope for direct visualization of the bile duct mucosa. This allows an endoscopist to obtain a visual impression (VI) and to perform targeted biopsy under direct visualization of the biliary stricture. The VI of a malignant biliary stricture is often characterized by the presence of intraductal abnormal tissue growth, and dilated, irregular, tortuous tumor vessels. During standard ERCP, cholangioscopy can be performed using a 2-operator "mother-baby" system, or a single-operator system. While the 2-operator "mother-baby" cholangioscopy technique can provide good image quality of the biliary stricture during ERCP, its use has been limited due to the cumbersome nature of the procedure requiring 2 endoscopists and the relative fragility of the video cholangioscope. Single-operator cholangioscopy (SOC) system, such as the SpyGlass Direct Visualization System, on the other hand allows a single operator to perform cholangioscopy during ERCP. In a recent meta-analysis of the studies using the optical fiber based SOC in the evaluation of indeterminate biliary strictures, the combined sensitivity and specificity of VI were 90% and 87% respectively, and the combined sensitivity and specificity of cholangioscopy directed biopsy were 69% and 98% respectively. The overall incidence of procedure-related adverse event (eg, infection, perforation, pancreatitis, etc) was reported to be 7.5% for diagnostic SOC during ERCP.
Despite the promising results of VI using the optical fiber based SOC from prior studies, the actual image quality in daily clinical practice is frequently regarded as fair only due to the use of a small optical fiber for imaging, and gradual loss of resolution over time from optical fiber damage. A SOC with better image quality is needed for better endoscopic diagnosis of a 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thomas Lam, BS
- Phone Number: 852-3505-3509
- Email: thomaslam@cuhk.edu.hk
Study Locations
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New Territories
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Sha Tin, New Territories, Hong Kong
- Recruiting
- Prince of Wales Hospital, The Chinese University of Hong Kong
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Contact:
- Thomas Lam, BS
- Phone Number: 852-3505-3509
- Email: thomaslam@cuhk.edu.hk
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Principal Investigator:
- Raymond S Tang, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SpyGlass DS Cholangioscopy
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sensitivity, specificity, and accuracy of the digital SOC during ERCP in the diagnosis of malignant and benign biliary strictures.
Time Frame: Till a diagnosis of a malignant stricture is made, or follow up period of at least 6 months for presumed benign stricture
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To assess the sensitivity, specificity, and accuracy of digital SOC in the diagnosis of biliary strictures
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Till a diagnosis of a malignant stricture is made, or follow up period of at least 6 months for presumed benign stricture
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Raymond S Tang, MD, Prince of Wales Hospital, The Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOC for biliary strictrure
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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