xml: <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/NCT05993429</url>
    </required_header>
    <id_info>
      <org_study_id>2023SDU-QILU-3</org_study_id>
      <nct_id>NCT05993429</nct_id>
    </id_info>
    <brief_title>Diagnostic Efficacy of EUS-FNA/B Versus ERCP With or Without POCS-TB in Patients With Suspected Hilar Cholangiocarcinoma</brief_title>
    <official_title>Diagnostic Efficacy of Endoscopic Ultrasound-guided Fine-needle Aspiration/Biopsy Versus Endoscopic Retrograde Cholangiopancreatography With or Without Peroral Cholangioscopy Targeted Biopsy for Suspected Hilar Cholangiocarcinoma: an Open Multicenter Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qilu Hospital of Shandong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Affiliated Hospital of Guangxi Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>LanZhou University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sir Run Run Shaw Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Wuhan Union Hospital, China</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Qilu Hospital of Shandong University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an observational study with a prospective cohort design. This study enrolled patients&#xD;
        with suspected hilar cholangiocarcinoma on imaging. This study aims to evaluate the&#xD;
        histopathological diagnostic efficacy of endoscopic ultrasound-guided fine-needle&#xD;
        aspiration/biopsy (EUS-FNA/B) and endoscopic retrograde cholangiopancreatography (ERCP) with&#xD;
        or without peroral cholangioscopy targeted biopsy (POCS-TB) in patients with suspected hilar&#xD;
        cholangiocarcinoma. In addition, the incidence of complications was compared between the&#xD;
        EUS-FNA/B and ERCP with or without POCS-TB. The impact of the histopathological diagnosis on&#xD;
        survival outcomes in patients with suspected hilar cholangiocarcinoma was evaluated.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The diagnostic value of EUS-FNA/B versus ERCP with or without POCS-TB in diagnosing hilar cholangiocarcinoma</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>The diagnostic value was assessed by sensitivity, specificity, accuracy, and positive and negative predictive values.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The incidence of complications</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>The incidence of complications after EUS-FNA/B versus ERCP with or without POCS-TB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The cost-effectiveness ratio</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>The cost-effectiveness ratio of EUS-FNA/B versus ERCP with or without POCS-TB in the diagnosis of hilar cholangiocarcinoma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The emergency readmission time</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>The emergency readmission time of EUS-FNA versus ERCP with or without POCS-TB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of tissue deemed adequate for cytological or histological analysis obtained by EUS-FNA/B and ERCP with or without POCS-TB.</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>The proportion of tissue deemed adequate for cytological or histological analysis obtained by EUS-FNA/B and ERCP with or without POCS-TB.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The number of participants whose visual diagnosis by the new generation of Eye Max cholangioscopy was consistent with the pathological and final diagnoses, respectively.</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>The number of participants whose visual diagnosis by the new generation of Eye Max cholangioscopy was consistent with the pathological and final diagnoses, respectively.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The number of participants whose management was affected by the new generation of Eye Max cholangioscopy visual diagnosis.</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>The number of participants whose management was affected by the new generation of Eye Max cholangioscopy visual diagnosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence rate of needle tract metastasis by EUS-FNA/B</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>The incidence rate of needle tract metastasis by EUS-FNA/B</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The number of participants whose further treatment strategies were impacted by preoperative pathological diagnosis.</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>The number of participants whose further treatment strategies were impacted by preoperative pathological diagnosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis.</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum lesion size</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>Maximum lesion size on EUS</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lesion shape</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>Lesion shape (ovoid-to-round, irregular) on EUS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lesion composition</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>Lesion composition (cystic, partially cystic, solid) on EUS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lesion margin</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>Lesion margin (ill-defined, microlobulated/spiculated, well-defined) on EUS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lesion echogenicity</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>Lesion echogenicity (hyperechoic intensity, isoechoic intensity, hypoechoic intensity) on EUS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lesion heterogeneity</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>Lesion heterogeneity on EUS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lesion growth pattern</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>Lesion growth pattern on EUS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lesion blood flow</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>Lesion blood flow (none, poor, moderate, rich) on EUS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lesion elastography</measure>
      <time_frame>2023-08-20 to 2027-08-01</time_frame>
      <description>Lesion elastography (stiff, moderate, soft, unvalued) on EUS.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Klatskin Tumor</condition>
    <condition>Cholangiocarcinoma</condition>
    <condition>Biopsy, Fine-Needle</condition>
    <condition>Endoscopic Retrograde Cholangiopancreatography</condition>
    <arm_group>
      <arm_group_label>EUS-FNA/B group; ERCP with or without POCS-TB group</arm_group_label>
      <description>EUS-FNA/B group: Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by EUS-FNA/B by experts</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ERCP with or without POCS-TB group</arm_group_label>
      <description>ERCP with or without POCS-TB group: Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by ERCP with or without POCS-TB by experts</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>The sampling method selected in patients with suspected hilar cholangiocarcinoma</intervention_name>
      <description>The appropriate sampling approach was selected as EUS-FNA/B or ERCP with or without POCS-TB based on experts' overall evaluation. This study will compare the histopathological diagnosis of the selected sampling method with the final diagnosis.</description>
      <arm_group_label>ERCP with or without POCS-TB group</arm_group_label>
      <arm_group_label>EUS-FNA/B group; ERCP with or without POCS-TB group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining&#xD;
          histopathological diagnosis by EUS-FNA/B or ERCP with or without POCS-TB by experts&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 18-80 years old;&#xD;
  &#xD;
            2. Newly diagnosed patients with suspected hilar cholangiocarcinoma on imaging&#xD;
               examination&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with a definite diagnosis of cholangiocarcinoma by imaging (enhanced CT, MRI,&#xD;
               or MRCP) and surgical candidacy within 3 months;&#xD;
  &#xD;
            2. Patients scheduled for liver transplantation;&#xD;
  &#xD;
            3. patients with previous gastroduodenal diversion or biliary surgery;&#xD;
  &#xD;
            4. Patients with hilar bile duct stenosis caused by tumor or lesion outside the bile&#xD;
               duct;&#xD;
  &#xD;
            5. Pregnant or lactating women;&#xD;
  &#xD;
            6. Patients who cannot tolerate intravenous general anesthesia due to various reasons;&#xD;
  &#xD;
            7. Patients with severe coagulation dysfunction, or patients who cannot stop&#xD;
               antiplatelet/anticoagulant therapy for a short time and are unsuitable for low&#xD;
               molecular weight heparin replacement therapy;&#xD;
  &#xD;
            8. Patients who refused to sign informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ning Zhong, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Qilu Hospital of Shandong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zhen Li, MD</last_name>
      <phone>18560086106</phone>
      <email>qilulizhen@sdu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Qilu Hospital of Shandong University</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250063</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cholangiocarcinoma</mesh_term>
      <mesh_term>Klatskin Tumor</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993429
  org study id: 2023SDU-QILU-3
  nct id: NCT05993429
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This is an observational study with a prospective cohort design. This study enrolled patients
        with suspected hilar cholangiocarcinoma on imaging. This study aims to evaluate the
        histopathological diagnostic efficacy of endoscopic ultrasound-guided fine-needle
        aspiration/biopsy (EUS-FNA/B) and endoscopic retrograde cholangiopancreatography (ERCP) with
        or without peroral cholangioscopy targeted biopsy (POCS-TB) in patients with suspected hilar
        cholangiocarcinoma. In addition, the incidence of complications was compared between the
        EUS-FNA/B and ERCP with or without POCS-TB. The impact of the histopathological diagnosis on
        survival outcomes in patients with suspected hilar cholangiocarcinoma was evaluated.
  observational model: Cohort
  time perspective: Prospective
  measure: The diagnostic value of EUS-FNA/B versus ERCP with or without POCS-TB in diagnosing hilar cholangiocarcinoma
  time frame: 2023-08-20 to 2027-08-01
  description: The diagnostic value was assessed by sensitivity, specificity, accuracy, and positive and negative predictive values.
  measure: The incidence of complications
  time frame: 2023-08-20 to 2027-08-01
  description: The incidence of complications after EUS-FNA/B versus ERCP with or without POCS-TB
  measure: The cost-effectiveness ratio
  time frame: 2023-08-20 to 2027-08-01
  description: The cost-effectiveness ratio of EUS-FNA/B versus ERCP with or without POCS-TB in the diagnosis of hilar cholangiocarcinoma
  measure: The emergency readmission time
  time frame: 2023-08-20 to 2027-08-01
  description: The emergency readmission time of EUS-FNA versus ERCP with or without POCS-TB
  measure: The proportion of tissue deemed adequate for cytological or histological analysis obtained by EUS-FNA/B and ERCP with or without POCS-TB.
  time frame: 2023-08-20 to 2027-08-01
  description: The proportion of tissue deemed adequate for cytological or histological analysis obtained by EUS-FNA/B and ERCP with or without POCS-TB.
  measure: The number of participants whose visual diagnosis by the new generation of Eye Max cholangioscopy was consistent with the pathological and final diagnoses, respectively.
  time frame: 2023-08-20 to 2027-08-01
  description: The number of participants whose visual diagnosis by the new generation of Eye Max cholangioscopy was consistent with the pathological and final diagnoses, respectively.
  measure: The number of participants whose management was affected by the new generation of Eye Max cholangioscopy visual diagnosis.
  time frame: 2023-08-20 to 2027-08-01
  description: The number of participants whose management was affected by the new generation of Eye Max cholangioscopy visual diagnosis.
  measure: The incidence rate of needle tract metastasis by EUS-FNA/B
  time frame: 2023-08-20 to 2027-08-01
  description: The incidence rate of needle tract metastasis by EUS-FNA/B
  measure: The number of participants whose further treatment strategies were impacted by preoperative pathological diagnosis.
  time frame: 2023-08-20 to 2027-08-01
  description: The number of participants whose further treatment strategies were impacted by preoperative pathological diagnosis.
  measure: The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis.
  time frame: 2023-08-20 to 2027-08-01
  description: The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis.
  measure: Maximum lesion size
  time frame: 2023-08-20 to 2027-08-01
  description: Maximum lesion size on EUS
  measure: Lesion shape
  time frame: 2023-08-20 to 2027-08-01
  description: Lesion shape (ovoid-to-round, irregular) on EUS.
  measure: Lesion composition
  time frame: 2023-08-20 to 2027-08-01
  description: Lesion composition (cystic, partially cystic, solid) on EUS.
  measure: Lesion margin
  time frame: 2023-08-20 to 2027-08-01
  description: Lesion margin (ill-defined, microlobulated/spiculated, well-defined) on EUS.
  measure: Lesion echogenicity
  time frame: 2023-08-20 to 2027-08-01
  description: Lesion echogenicity (hyperechoic intensity, isoechoic intensity, hypoechoic intensity) on EUS.
  measure: Lesion heterogeneity
  time frame: 2023-08-20 to 2027-08-01
  description: Lesion heterogeneity on EUS.
  measure: Lesion growth pattern
  time frame: 2023-08-20 to 2027-08-01
  description: Lesion growth pattern on EUS.
  measure: Lesion blood flow
  time frame: 2023-08-20 to 2027-08-01
  description: Lesion blood flow (none, poor, moderate, rich) on EUS.
  measure: Lesion elastography
  time frame: 2023-08-20 to 2027-08-01
  description: Lesion elastography (stiff, moderate, soft, unvalued) on EUS.
  arm group label: EUS-FNA/B group; ERCP with or without POCS-TB group
  description: EUS-FNA/B group: Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by EUS-FNA/B by experts
  arm group label: ERCP with or without POCS-TB group
  description: ERCP with or without POCS-TB group: Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by ERCP with or without POCS-TB by experts
  intervention type: Diagnostic Test
  intervention name: The sampling method selected in patients with suspected hilar cholangiocarcinoma
  description: The appropriate sampling approach was selected as EUS-FNA/B or ERCP with or without POCS-TB based on experts' overall evaluation. This study will compare the histopathological diagnosis of the selected sampling method with the final diagnosis.
  arm group label: ERCP with or without POCS-TB group
  arm group label: EUS-FNA/B group; ERCP with or without POCS-TB group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Ning Zhong, MD
  role: Principal Investigator
  affiliation: Qilu Hospital of Shandong University
  last name: Zhen Li, MD
  phone: 18560086106
  email: qilulizhen@sdu.edu.cn
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Cholangiocarcinoma
  mesh term: Klatskin Tumor
  sharing ipd: No