<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03307382</url>
  </required_header>
  <id_info>
    <org_study_id>SOC for biliary strictrure</org_study_id>
    <nct_id>NCT03307382</nct_id>
  </id_info>
  <brief_title>Single-operator Digital Cholangioscopy for the Diagnosis of Malignant and Benign Biliary Strictures</brief_title>
  <official_title>Evaluation of the Utility of Single-operator Digital Cholangioscopy During Endoscopic Retrograde Cholangiopancreatography in the Diagnosis of Malignant and Benign Biliary Strictures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Differentiation between malignant and benign biliary strictures can be challenging. Accurate&#xD;
      differentiation of malignant biliary strictures from benign ones is crucial to guide&#xD;
      management decisions.&#xD;
&#xD;
      While conventional tissue acquisition techniques such as brush cytology or intraductal biopsy&#xD;
      of the biliary stricture is often performed during ERCP for tissue diagnosis, their&#xD;
      sensitivities are suboptimal. The average sensitivities for brush cytology and intraductal&#xD;
      biopsy were reported to be ~ 59% and ~ 63% respectively.&#xD;
&#xD;
      When the cause of a biliary stricture remains unclear despite conventional ERCP techniques&#xD;
      for diagnosis, cholangioscopy is often performed during ERCP to clarify the diagnosis. This&#xD;
      allows an endoscopist to obtain a visual impression (VI) and to perform targeted biopsy under&#xD;
      direct visualization of the biliary stricture.&#xD;
&#xD;
      Recently, a digital SOC system (SpyGlass Digital System (SpyGlass DS), Boston Scientific,&#xD;
      USA) has become available and has the potential to further improve the diagnosis of malignant&#xD;
      and benign biliary strictures. The utility of this digital SOC in the evaluation of biliary&#xD;
      strictures has not been well studied. We propose this study to evaluate the utility of the&#xD;
      digital SOC during ERCP in the diagnosis of malignant and benign biliary strictures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Differentiation between malignant and benign biliary strictures can be challenging. Accurate&#xD;
      differentiation of malignant biliary strictures from benign ones is crucial to guide&#xD;
      management decisions. While a mass lesion involving the bile duct may be observed on imaging&#xD;
      such as ultrasound (USG), computed tomography (CT), or magnetic resonance imaging (MRI) in&#xD;
      patient presenting with obstructive jaundice, early malignancy of the bile duct may often&#xD;
      present with a ductal stricture without an obvious mass on imaging. Diagnosis of early stage&#xD;
      malignancy of the bile duct is desirable since the lesion may be amenable to surgical&#xD;
      resection of curative intent.&#xD;
&#xD;
      Endoscopic retrograde cholangiopancreatography (ERCP) is an important diagnostic and&#xD;
      therapeutic endoscopic technique in patients with obstructive jaundice and a suspected&#xD;
      biliary stricture. While conventional tissue acquisition techniques such as brush cytology or&#xD;
      intraductal biopsy of the biliary stricture is often performed during ERCP for tissue&#xD;
      diagnosis, their sensitivities are suboptimal. The average sensitivities for brush cytology&#xD;
      and intraductal biopsy were reported to be ~ 59% and ~ 63% respectively.&#xD;
&#xD;
      When the cause of a biliary stricture remains unclear despite conventional ERCP techniques&#xD;
      for diagnosis, cholangioscopy is often performed during ERCP to clarify the diagnosis.&#xD;
      Cholangioscopy performed during ERCP involves passing a small scope (~ 10 French in size)&#xD;
      through the working channel of the ERCP duodenoscope for direct visualization of the bile&#xD;
      duct mucosa. This allows an endoscopist to obtain a visual impression (VI) and to perform&#xD;
      targeted biopsy under direct visualization of the biliary stricture. The VI of a malignant&#xD;
      biliary stricture is often characterized by the presence of intraductal abnormal tissue&#xD;
      growth, and dilated, irregular, tortuous tumor vessels. During standard ERCP, cholangioscopy&#xD;
      can be performed using a 2-operator &quot;mother-baby&quot; system, or a single-operator system. While&#xD;
      the 2-operator &quot;mother-baby&quot; cholangioscopy technique can provide good image quality of the&#xD;
      biliary stricture during ERCP, its use has been limited due to the cumbersome nature of the&#xD;
      procedure requiring 2 endoscopists and the relative fragility of the video cholangioscope.&#xD;
      Single-operator cholangioscopy (SOC) system, such as the SpyGlass Direct Visualization&#xD;
      System, on the other hand allows a single operator to perform cholangioscopy during ERCP. In&#xD;
      a recent meta-analysis of the studies using the optical fiber based SOC in the evaluation of&#xD;
      indeterminate biliary strictures, the combined sensitivity and specificity of VI were 90% and&#xD;
      87% respectively, and the combined sensitivity and specificity of cholangioscopy directed&#xD;
      biopsy were 69% and 98% respectively. The overall incidence of procedure-related adverse&#xD;
      event (eg, infection, perforation, pancreatitis, etc) was reported to be 7.5% for diagnostic&#xD;
      SOC during ERCP.&#xD;
&#xD;
      Despite the promising results of VI using the optical fiber based SOC from prior studies, the&#xD;
      actual image quality in daily clinical practice is frequently regarded as fair only due to&#xD;
      the use of a small optical fiber for imaging, and gradual loss of resolution over time from&#xD;
      optical fiber damage. A SOC with better image quality is needed for better endoscopic&#xD;
      diagnosis of a biliary stricture.&#xD;
&#xD;
      Recently, a digital SOC system (SpyGlass Digital System (SpyGlass DS), Boston Scientific,&#xD;
      USA) has become available and has the potential to further improve the diagnosis of malignant&#xD;
      and benign biliary strictures. The utility of this digital SOC in the evaluation of biliary&#xD;
      strictures has not been well studied. We propose this study to evaluate the utility of the&#xD;
      digital SOC during ERCP in the diagnosis of malignant and benign biliary strictures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 15, 2015</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Cohort study</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sensitivity, specificity, and accuracy of the digital SOC during ERCP in the diagnosis of malignant and benign biliary strictures.</measure>
    <time_frame>Till a diagnosis of a malignant stricture is made, or follow up period of at least 6 months for presumed benign stricture</time_frame>
    <description>To assess the sensitivity, specificity, and accuracy of digital SOC in the diagnosis of biliary strictures</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Biliary Stricture</condition>
  <arm_group>
    <arm_group_label>SpyGlass DS Cholangioscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SpyGlass DS Cholangioscopy</intervention_name>
    <description>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.</description>
    <arm_group_label>SpyGlass DS Cholangioscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Patients presenting with obstructive jaundice with clinical suspicion for a biliary&#xD;
             stricture based on imaging findings or during ERCP&#xD;
&#xD;
          -  Written informed consent available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for endoscopy due to comorbidities&#xD;
&#xD;
          -  Unable to provide written informed consent&#xD;
&#xD;
          -  Patients with clinical evidence of ongoing cholangitis precluding a safe&#xD;
             cholangioscopy procedure&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Moribund patients from terminal illnesses&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raymond S Tang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prince of Wales Hospital, The Chinese University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas Lam, BS</last_name>
    <phone>852-3505-3509</phone>
    <email>thomaslam@cuhk.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Prince of Wales Hospital, The Chinese University of Hong Kong</name>
      <address>
        <city>Sha Tin</city>
        <state>New Territories</state>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Lam, BS</last_name>
      <phone>852-3505-3509</phone>
      <email>thomaslam@cuhk.edu.hk</email>
    </contact>
    <investigator>
      <last_name>Raymond S Tang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>August 20, 2023</last_update_submitted>
  <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Raymond Shing Yan Tang</investigator_full_name>
    <investigator_title>Clinical Professional Consultant</investigator_title>
  </responsible_party>
  <keyword>Biliary stricture, cholangioscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholestasis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03307382
org study id: SOC for biliary strictrure
nct id: NCT03307382
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Cohort study
primary purpose: Diagnostic
masking: None (Open Label)
measure: 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
description: To assess the sensitivity, specificity, and accuracy of digital SOC in the diagnosis of biliary strictures
arm group label: SpyGlass DS Cholangioscopy
arm group type: Experimental
description: 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.
intervention type: Device
intervention name: SpyGlass DS Cholangioscopy
description: 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.
arm group label: SpyGlass DS Cholangioscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raymond S Tang, MD
role: Principal Investigator
affiliation: Prince of Wales Hospital, The Chinese University of Hong Kong
last name: Thomas Lam, BS
phone: 852-3505-3509
email: thomaslam@cuhk.edu.hk
facility: 
status: Recruiting
contact: 
investigator: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Raymond Shing Yan Tang
investigator title: Clinical Professional Consultant
mesh term: Cholestasis
mesh term: Constriction, Pathologic
sharing ipd: No