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/NCT06010576</url>
    </required_header>
    <id_info>
      <org_study_id>2021.720-T</org_study_id>
      <nct_id>NCT06010576</nct_id>
    </id_info>
    <brief_title>Endoscopic Ultrasound-guided Rendezvous Versus Precut Papillotomy</brief_title>
    <acronym>ERVPP</acronym>
    <official_title>Endoscopic Ultrasound-guided Rendezvous Technique Versus Early Precut Papillotomy for Difficult Bile Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography: a Multicenter Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chinese University of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Tokyo University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Gifu University Graduate School of Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Chinese University of Hong Kong</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Selective bile duct cannulation is the most important step in endoscopic retrograde&#xD;
        cholangiopancreatography (ERCP) for treatment of benign and malignant pancreatobiliary&#xD;
        diseases, but it may fail in up to 15% of cases. Precut papillotomy is an advanced ERCP&#xD;
        cannulation technique recommended by guidelines for rescue of difficult biliary access, but&#xD;
        it is not without limitations. Endoscopic ultrasound (EUS)-guided biliary drainage is a novel&#xD;
        interventional EUS technique that has been increasingly performed after failed biliary access&#xD;
        by advanced ERCP cannulation techniques.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Endoscopic retrograde cholangiopancreatography (ERCP) is the preferred therapeutic modality&#xD;
        over surgery or interventional radiology procedures in many common benign or malignant&#xD;
        pancreatobiliary diseases in modern clinical practice, but selective bile duct cannulation&#xD;
        may fail in up to 15% of cases.&#xD;
  &#xD;
        The implication of failed endoscopic biliary access can be substantial for the following&#xD;
        reasons: higher risk of post-ERCP pancreatitis (PEP), need for rescue procedures such as&#xD;
        external biliary drainage by interventional radiology, risks of external biliary drainage&#xD;
        catheter-related complications including catheter blockage.&#xD;
  &#xD;
        Advanced ERCP cannulation techniques such as pancreatic guidewire-assisted biliary&#xD;
        cannulation with or without pancreatic stenting, and precut papillotomy are recommended by&#xD;
        guidelines in patients with difficult bile duct cannulation, but they are not without&#xD;
        limitations. If pancreatic duct cannulation is not feasible or pancreatic guidewire-assisted&#xD;
        biliary cannulation fails, precut papillotomy using 1 of the 3 accepted precut techniques: 1)&#xD;
        conventional precut papillotomy by needle knife, 2) precut fistulotomy by needle knife, or 3)&#xD;
        transpancreatic precut papillotomy by papillotome, can be performed depending on&#xD;
        institutional expertise. Despite a higher biliary cannulation success by precut papillotomy&#xD;
        when compared to pancreatic guidewire-assisted biliary cannulation, a higher risk of PEP has&#xD;
        also been traditionally associated with precut papillotomy when it is performed after&#xD;
        prolonged cannulation attempts. On the other hand, there has been growing evidence to suggest&#xD;
        the increased risk of PEP may be related to the persistent cannulation attempts before precut&#xD;
        rather than the precut papillotomy itself. In a recent meta-analysis of 5 randomized&#xD;
        controlled trials comparing &quot;early precut papillotomy&quot; to persistent standard cannulation&#xD;
        techniques in ERCP by attending endoscopists and advanced endoscopy trainees, the incidence&#xD;
        of PEP was not significantly different between the &quot;early precut papillotomy&quot; and the&#xD;
        persistent standard cannulation groups.&#xD;
  &#xD;
        EUS-guided rendezvous technique (EUS RV) is a novel advanced interventional EUS technique&#xD;
        that has been increasingly performed in tertiary centers for patients with failed biliary&#xD;
        access by advanced ERCP cannulation techniques. Several variations of EUS-guided biliary&#xD;
        drainage procedures have been described including transpapillary drainage procedures (EUS RV&#xD;
        for biliary access, EUS-guided antegrade stenting) and transmural drainage procedures&#xD;
        (EUS-guided choledochoduodenostomy, EUS-guided hepaticogastrostomy). EUS RV can be applied in&#xD;
        both benign and malignant biliary conditions as a salvage technique for difficult biliary&#xD;
        access when the major papilla is accessible. EUS RV involves the following key steps: access&#xD;
        of the dilated bile duct by a EUS needle under EUS guidance, performance of cholangiogram,&#xD;
        advancement of the rendezvous guidewire into the bile duct and out of the major papilla into&#xD;
        duodenum, and exchange of echoendoscope back to a duodenoscope to complete the procedure by&#xD;
        retrieving the rendezvous guidewire into the duodenoscope or by cannulation alongside the&#xD;
        rendezvous guidewire. Because EUS RV achieves biliary access by targeting the dilated bile&#xD;
        duct with antegrade passage of guidewire from bile duct through the papillary orifice,&#xD;
        theoretically this would carry a lower risk of procedure-related PEP when compared to early&#xD;
        precut papillotomy.&#xD;
  &#xD;
        In a recently published consensus guidelines on the optimal management in interventional EUS&#xD;
        procedures proposed by experts from our endoscopy research group and other member&#xD;
        institutions of the Asian EUS Group, EUS-guided biliary drainage is recommended as the&#xD;
        procedure of choice for biliary drainage in patients with failed ERCP when expertise is&#xD;
        available based on high level evidence. The technical success of EUS RV has increased over&#xD;
        time to 73% to 100% in studies published after 2012.&#xD;
  &#xD;
        Studies directly comparing EUS RV and precut papillotomy in patients with difficult biliary&#xD;
        access remain scarce. In a single center retrospective study published in 2012 comparing the&#xD;
        clinical outcomes of 58 EUS RV procedures and 144 precut papillotomy procedures in patients&#xD;
        with failed bile duct cannulation in ERCP, Dhir V et al reported a significantly higher first&#xD;
        session technical success of biliary access (98% vs 90%, p = 0.038) and a lower adverse event&#xD;
        rate (3.4% vs 6.9%, p = 0.27) in the EUS RV group. In a multicenter retrospective study&#xD;
        published in 2017 by Lee A et al comparing the clinical outcomes of 50 EUS RV + 11 EUS-guided&#xD;
        transmural drainage procedures and 142 precut papillotomy procedures in patients with failed&#xD;
        bile duct cannulation in ERCP, a higher technical success of biliary access (94% vs 75%) was&#xD;
        also demonstrated in the EUS RV group.&#xD;
  &#xD;
        Despite the promising results of EUS RV in patients with failed biliary cannulation by&#xD;
        advanced ERCP techniques, there has been no dedicated randomized controlled trial directly&#xD;
        comparing EUS RV and early precut papillotomy in patients with difficult bile duct&#xD;
        cannulation. We aim to conduct a multicenter randomized controlled trial comparing the&#xD;
        clinical efficacy of these 2 advanced endoscopic biliary access techniques in patients with&#xD;
        difficult bile duct cannulation in ERCP.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 5, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The first session technical success for biliary access by EUS-guided rendezvous technique and early precut papillotomy in patients with difficult biliary access during ERCP</measure>
      <time_frame>Intra-procedure, during ERCP</time_frame>
      <description>Technical success by EUS RV is defined as successful EUS-guided needle access of bile duct confirmed by bile aspiration and cholangiogram, advancement of guidewire into bile duct and out of papilla, and obtaining deep biliary cannulation by retrieving the rendezvous guidewire into duodenoscope or by cannulation alongside the rendezvous guidewire. Technical success by Early Precut Papillotomy is defined as successful bile duct access by 1 of the 3 acceptable precut techniques in achieving deep biliary cannulation, confirmed by bile aspiration and cholangiogram.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Procedure-related serious adverse events in the EUS-guided rendezvous group and the early precut papillotomy group within 30 days of ERCP</measure>
      <time_frame>From day of procedure to Day 30 after procedure</time_frame>
      <description>Procedure-related serious adverse events include perforation, bleeding, biliary sepsis, pancreatitis, bile leak, or procedure-related mortality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Procedure time to achieve biliary access by the assigned study biliary access technique</measure>
      <time_frame>Intra-procedure, during ERCP</time_frame>
      <description>EUS RV group: time from EUS-guided needle access of bile duct to successful biliary cannulation by ERCP. Early Precut Papillotomy group: time from precut initiation to successful biliary cannulation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Need for rescue biliary drainage procedures in patients with failed biliary access by the assigned study technique, including crossover to the other study biliary access technique, need for PTBD by interventional radiology</measure>
      <time_frame>Intra-procedure (during ERCP) and 3 days post procedure</time_frame>
      <description>Intra-procedure: crossover to the other study biliary access technique. Within 3 days of procedure: need for percutaneous transhepatic biliary drainage by interventional radiology</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">188</enrollment>
    <condition>Bile Duct Diseases</condition>
    <arm_group>
      <arm_group_label>EUS-guided rendezvous group (EUS RV group)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In the EUS RV group, a linear array echoendoscope would be used to evaluate the common bile duct and left intrahepatic duct in order to identify the optimal route for biliary access by fine needle. Using a 19 gauge EUS needle, the dilated biliary tree will be accessed by either a transduodenal puncture to the common bile duct or a transgastric puncture to the left intrahepatic duct under direct EUS guidance. The optimal access route will be based on patient's anatomy after EUS assessment and left to the discretion of the investigator. Next, a guidewire would be advanced through the needle into the bile duct and out of the papillary orifice. The echoendoscope would then be exchanged to a duodenoscope for ERCP. The EUS rendezvous ERCP procedure will be completed by retrieving the rendezvous guidewire into the duodenoscope or by cannulation alongside the rendezvous guidewire to obtain biliary access.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Early precut papillotomy group (EPP group)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In the EPP group, the precut papillotomy would be performed with 1 of the following acceptable techniques per the usual practice of the study investigator and institution: 1) conventional precut papillotomy by needle knife, 2) precut fistulotomy by needle knife, or 3) transpancreatic precut papillotomy by papillotome</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>EUS-guided rendezvous</intervention_name>
      <description>A linear array echoendoscope would be used to evaluate the common bile duct and left intrahepatic duct in order to identify the optimal route for biliary access by fine needle. Using a 19 gauge EUS needle, the dilated biliary tree will be accessed by either a transduodenal puncture to the common bile duct or a transgastric puncture to the left intrahepatic duct under direct EUS guidance. The optimal access route will be based on patient's anatomy after EUS assessment and left to the discretion of the investigator. Next, a guidewire would be advanced through the needle into the bile duct and out of the papillary orifice. The echoendoscope would then be exchanged to a duodenoscope for ERCP. The EUS rendezvous ERCP procedure will be completed by retrieving the rendezvous guidewire into the duodenoscope or by cannulation alongside the rendezvous guidewire to obtain biliary access.</description>
      <arm_group_label>EUS-guided rendezvous group (EUS RV group)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Early precut papillotomy group</intervention_name>
      <description>The precut papillotomy would be performed with 1 of the following acceptable techniques per the usual practice of the study investigator and institution: 1) conventional precut papillotomy by needle knife, 2) precut fistulotomy by needle knife, or 3) transpancreatic precut papillotomy by papillotome</description>
      <arm_group_label>Early precut papillotomy group (EPP group)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients age 18 years or older undergoing ERCP with indication for bile duct&#xD;
               cannulation&#xD;
  &#xD;
            -  Native major papilla&#xD;
  &#xD;
            -  Difficult bile duct cannulation, defined by the presence of 1 of the following: 1)&#xD;
               unsuccessful bile duct cannulation within 10 cannulation attempts, 2) unsuccessful&#xD;
               bile duct cannulation within 10 minutes spent in cannulation, or 3) 2 unintended&#xD;
               pancreatic duct cannulation or opacification with contrast&#xD;
  &#xD;
            -  Written informed consent available&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to provide written informed consent&#xD;
  &#xD;
            -  Contraindications for endoscopy due to comorbidities&#xD;
  &#xD;
            -  Prior biliary sphincterotomy&#xD;
  &#xD;
            -  Surgically altered upper gastrointestinal anatomy or duodenal obstruction precluding a&#xD;
               standard ERCP&#xD;
  &#xD;
            -  Uncorrectable coagulopathy (INR &gt; 1.5) and thrombocytopenia (platelet &lt; 50,000) by&#xD;
               blood product transfusion&#xD;
  &#xD;
            -  Pregnant patients&#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 Tang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chinese University of Hong Kong</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Felix Sia</last_name>
      <phone>26370428</phone>
      <email>felixsia@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>Felix Sia, BS</last_name>
        <phone>(852) 26370428</phone>
        <email>felixsia@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>September 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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>Assitant Professor</investigator_title>
    </responsible_party>
    <keyword>ERCP, EUS</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bile Duct Diseases</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/NCT06010576
  org study id: 2021.720-T
  nct id: NCT06010576
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Selective bile duct cannulation is the most important step in endoscopic retrograde
        cholangiopancreatography (ERCP) for treatment of benign and malignant pancreatobiliary
        diseases, but it may fail in up to 15% of cases. Precut papillotomy is an advanced ERCP
        cannulation technique recommended by guidelines for rescue of difficult biliary access, but
        it is not without limitations. Endoscopic ultrasound (EUS)-guided biliary drainage is a novel
        interventional EUS technique that has been increasingly performed after failed biliary access
        by advanced ERCP cannulation techniques.
  Endoscopic retrograde cholangiopancreatography (ERCP) is the preferred therapeutic modality
        over surgery or interventional radiology procedures in many common benign or malignant
        pancreatobiliary diseases in modern clinical practice, but selective bile duct cannulation
        may fail in up to 15% of cases.
  
        The implication of failed endoscopic biliary access can be substantial for the following
        reasons: higher risk of post-ERCP pancreatitis (PEP), need for rescue procedures such as
        external biliary drainage by interventional radiology, risks of external biliary drainage
        catheter-related complications including catheter blockage.
  
        Advanced ERCP cannulation techniques such as pancreatic guidewire-assisted biliary
        cannulation with or without pancreatic stenting, and precut papillotomy are recommended by
        guidelines in patients with difficult bile duct cannulation, but they are not without
        limitations. If pancreatic duct cannulation is not feasible or pancreatic guidewire-assisted
        biliary cannulation fails, precut papillotomy using 1 of the 3 accepted precut techniques: 1)
        conventional precut papillotomy by needle knife, 2) precut fistulotomy by needle knife, or 3)
        transpancreatic precut papillotomy by papillotome, can be performed depending on
        institutional expertise. Despite a higher biliary cannulation success by precut papillotomy
        when compared to pancreatic guidewire-assisted biliary cannulation, a higher risk of PEP has
        also been traditionally associated with precut papillotomy when it is performed after
        prolonged cannulation attempts. On the other hand, there has been growing evidence to suggest
        the increased risk of PEP may be related to the persistent cannulation attempts before precut
        rather than the precut papillotomy itself. In a recent meta-analysis of 5 randomized
        controlled trials comparing "early precut papillotomy" to persistent standard cannulation
        techniques in ERCP by attending endoscopists and advanced endoscopy trainees, the incidence
        of PEP was not significantly different between the "early precut papillotomy" and the
        persistent standard cannulation groups.
  
        EUS-guided rendezvous technique (EUS RV) is a novel advanced interventional EUS technique
        that has been increasingly performed in tertiary centers for patients with failed biliary
        access by advanced ERCP cannulation techniques. Several variations of EUS-guided biliary
        drainage procedures have been described including transpapillary drainage procedures (EUS RV
        for biliary access, EUS-guided antegrade stenting) and transmural drainage procedures
        (EUS-guided choledochoduodenostomy, EUS-guided hepaticogastrostomy). EUS RV can be applied in
        both benign and malignant biliary conditions as a salvage technique for difficult biliary
        access when the major papilla is accessible. EUS RV involves the following key steps: access
        of the dilated bile duct by a EUS needle under EUS guidance, performance of cholangiogram,
        advancement of the rendezvous guidewire into the bile duct and out of the major papilla into
        duodenum, and exchange of echoendoscope back to a duodenoscope to complete the procedure by
        retrieving the rendezvous guidewire into the duodenoscope or by cannulation alongside the
        rendezvous guidewire. Because EUS RV achieves biliary access by targeting the dilated bile
        duct with antegrade passage of guidewire from bile duct through the papillary orifice,
        theoretically this would carry a lower risk of procedure-related PEP when compared to early
        precut papillotomy.
  
        In a recently published consensus guidelines on the optimal management in interventional EUS
        procedures proposed by experts from our endoscopy research group and other member
        institutions of the Asian EUS Group, EUS-guided biliary drainage is recommended as the
        procedure of choice for biliary drainage in patients with failed ERCP when expertise is
        available based on high level evidence. The technical success of EUS RV has increased over
        time to 73% to 100% in studies published after 2012.
  
        Studies directly comparing EUS RV and precut papillotomy in patients with difficult biliary
        access remain scarce. In a single center retrospective study published in 2012 comparing the
        clinical outcomes of 58 EUS RV procedures and 144 precut papillotomy procedures in patients
        with failed bile duct cannulation in ERCP, Dhir V et al reported a significantly higher first
        session technical success of biliary access (98% vs 90%, p = 0.038) and a lower adverse event
        rate (3.4% vs 6.9%, p = 0.27) in the EUS RV group. In a multicenter retrospective study
        published in 2017 by Lee A et al comparing the clinical outcomes of 50 EUS RV + 11 EUS-guided
        transmural drainage procedures and 142 precut papillotomy procedures in patients with failed
        bile duct cannulation in ERCP, a higher technical success of biliary access (94% vs 75%) was
        also demonstrated in the EUS RV group.
  
        Despite the promising results of EUS RV in patients with failed biliary cannulation by
        advanced ERCP techniques, there has been no dedicated randomized controlled trial directly
        comparing EUS RV and early precut papillotomy in patients with difficult bile duct
        cannulation. We aim to conduct a multicenter randomized controlled trial comparing the
        clinical efficacy of these 2 advanced endoscopic biliary access techniques in patients with
        difficult bile duct cannulation in ERCP.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The first session technical success for biliary access by EUS-guided rendezvous technique and early precut papillotomy in patients with difficult biliary access during ERCP
  time frame: Intra-procedure, during ERCP
  description: Technical success by EUS RV is defined as successful EUS-guided needle access of bile duct confirmed by bile aspiration and cholangiogram, advancement of guidewire into bile duct and out of papilla, and obtaining deep biliary cannulation by retrieving the rendezvous guidewire into duodenoscope or by cannulation alongside the rendezvous guidewire. Technical success by Early Precut Papillotomy is defined as successful bile duct access by 1 of the 3 acceptable precut techniques in achieving deep biliary cannulation, confirmed by bile aspiration and cholangiogram.
  measure: Procedure-related serious adverse events in the EUS-guided rendezvous group and the early precut papillotomy group within 30 days of ERCP
  time frame: From day of procedure to Day 30 after procedure
  description: Procedure-related serious adverse events include perforation, bleeding, biliary sepsis, pancreatitis, bile leak, or procedure-related mortality
  measure: Procedure time to achieve biliary access by the assigned study biliary access technique
  time frame: Intra-procedure, during ERCP
  description: EUS RV group: time from EUS-guided needle access of bile duct to successful biliary cannulation by ERCP. Early Precut Papillotomy group: time from precut initiation to successful biliary cannulation.
  measure: Need for rescue biliary drainage procedures in patients with failed biliary access by the assigned study technique, including crossover to the other study biliary access technique, need for PTBD by interventional radiology
  time frame: Intra-procedure (during ERCP) and 3 days post procedure
  description: Intra-procedure: crossover to the other study biliary access technique. Within 3 days of procedure: need for percutaneous transhepatic biliary drainage by interventional radiology
  arm group label: EUS-guided rendezvous group (EUS RV group)
  arm group type: Active Comparator
  description: In the EUS RV group, a linear array echoendoscope would be used to evaluate the common bile duct and left intrahepatic duct in order to identify the optimal route for biliary access by fine needle. Using a 19 gauge EUS needle, the dilated biliary tree will be accessed by either a transduodenal puncture to the common bile duct or a transgastric puncture to the left intrahepatic duct under direct EUS guidance. The optimal access route will be based on patient's anatomy after EUS assessment and left to the discretion of the investigator. Next, a guidewire would be advanced through the needle into the bile duct and out of the papillary orifice. The echoendoscope would then be exchanged to a duodenoscope for ERCP. The EUS rendezvous ERCP procedure will be completed by retrieving the rendezvous guidewire into the duodenoscope or by cannulation alongside the rendezvous guidewire to obtain biliary access.
  arm group label: Early precut papillotomy group (EPP group)
  arm group type: Active Comparator
  description: In the EPP group, the precut papillotomy would be performed with 1 of the following acceptable techniques per the usual practice of the study investigator and institution: 1) conventional precut papillotomy by needle knife, 2) precut fistulotomy by needle knife, or 3) transpancreatic precut papillotomy by papillotome
  intervention type: Procedure
  intervention name: EUS-guided rendezvous
  description: A linear array echoendoscope would be used to evaluate the common bile duct and left intrahepatic duct in order to identify the optimal route for biliary access by fine needle. Using a 19 gauge EUS needle, the dilated biliary tree will be accessed by either a transduodenal puncture to the common bile duct or a transgastric puncture to the left intrahepatic duct under direct EUS guidance. The optimal access route will be based on patient's anatomy after EUS assessment and left to the discretion of the investigator. Next, a guidewire would be advanced through the needle into the bile duct and out of the papillary orifice. The echoendoscope would then be exchanged to a duodenoscope for ERCP. The EUS rendezvous ERCP procedure will be completed by retrieving the rendezvous guidewire into the duodenoscope or by cannulation alongside the rendezvous guidewire to obtain biliary access.
  arm group label: EUS-guided rendezvous group (EUS RV group)
  intervention type: Procedure
  intervention name: Early precut papillotomy group
  description: The precut papillotomy would be performed with 1 of the following acceptable techniques per the usual practice of the study investigator and institution: 1) conventional precut papillotomy by needle knife, 2) precut fistulotomy by needle knife, or 3) transpancreatic precut papillotomy by papillotome
  arm group label: Early precut papillotomy group (EPP group)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Raymond Tang, MD
  role: Principal Investigator
  affiliation: Chinese University of Hong Kong
  last name: Felix Sia
  phone: 26370428
  email: felixsia@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: Assitant Professor
  mesh term: Bile Duct Diseases
  sharing ipd: No