<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/NCT01686425</url>
  </required_header>
  <id_info>
    <org_study_id>ML8383</org_study_id>
    <nct_id>NCT01686425</nct_id>
  </id_info>
  <brief_title>Percutaneous Transhepatic Cholangiography Versus Endoscopic Ultrasound Guided Biliary Drainage</brief_title>
  <acronym>PETRUS</acronym>
  <official_title>Percutaneous Transhepatic Cholangiography Versus Endoscopic Ultrasound Guided Biliary Drainage in Advanced Biliary Tract Malignancy That Failed ERCP (PETRUS Study): A Randomized Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with obstructive jaundice due to locally advanced/metastatic malignancy with dilated&#xD;
      intrahepatic bile ducts will be recruited from the department of Gastroenterology and&#xD;
      Hepatology at the University Hospital of Leuven.&#xD;
&#xD;
      This population will have failed ERCP or will be considered when ERCP is not possible due to&#xD;
      altered surgical anatomy.&#xD;
&#xD;
      Patients will be randomized to either PTC or EUS guided biliary drainage&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Advanced biliary tract malignancy complicated by obstructive jaundice has been traditionally&#xD;
      managed by palliative stent placement at ERCP. In 3-12% of patients with advanced disease&#xD;
      tumour involvement of the small bowel or peri-ampullary region may preclude the use of ERCP&#xD;
      necessitating percutaneous transhepatic biliary drainage (PTBD) or surgery1. However these&#xD;
      techniques have been associated with high complication rates and significant morbidity2. PTBD&#xD;
      necessitates traversing the parietal and visceral peritoneum causing a potential for a bile&#xD;
      leak and bleeding into the peritoneal cavity. This procedure is also associated with&#xD;
      significant pain, lengthy hospital stays and an overall reduction in quality of life, and&#xD;
      even procedure related mortality. Indeed the Society of Interventional Radiology (SIR)&#xD;
      quality improvements guidelines established the procedural risk of severe major complications&#xD;
      including sepsis, bleeding and procedural related death at 2.5% and less severe complications&#xD;
      including pain and prolonged hospital admissions at 20%.&#xD;
&#xD;
      In recent years various groups have described endoscopic ultrasound guided access of the left&#xD;
      system allowing placement of metal or plastic stents either across the distal stricture or&#xD;
      deploying the stent in the stomach (hepatico-gastrostomy), with high technical success3.&#xD;
      Retrograde cannulation normally performed from the duodenal bulb allows access to the biliary&#xD;
      tract above a malignant stricture with the intent to either pass a guide wire through the&#xD;
      papilla and then perform a rendezvous procedure, or the placement of a covered metal stent&#xD;
      into the stomach (choledochoenterostomy)10. Cannulation of a dilated segment 2 or 3 sectoral&#xD;
      duct is also possible from the proximal stomach where the endoscopist performs all procedures&#xD;
      in an antegrade fashion5. Currently these procedures are selectively performed in centres by&#xD;
      expert endoscopists from mainly tertiary care academic expert centres including in Leuven.&#xD;
      Collectively EUS biliary drainage is technically successful in 75-92% of cases, however&#xD;
      reports of bile leaking and peritonitis have been described5.&#xD;
&#xD;
      Various obstacles however still exist to extend the general applicability of this technique&#xD;
      outside expert centres. Firstly, no randomized control trials exist comparing the safety and&#xD;
      efficacy of EUS biliary access to Percutaneous Transhepatic Cholangiography (PTC). Secondly,&#xD;
      current endoscopic techniques utilize standard endoscopic accessories not specifically&#xD;
      developed to be utilized within the biliary system when advanced through the gastric wall.&#xD;
      Thirdly, specific EUS strategies are needed to prevent or reduce complications associated&#xD;
      with percutaneous approaches.&#xD;
&#xD;
      Concept and preliminary experimental data&#xD;
&#xD;
      Hypothesis&#xD;
&#xD;
      Based on the literature we hypothesize that:&#xD;
&#xD;
        -  Endoscopic ultrasound guided biliary drainage is more effective than percutaneous&#xD;
           biliary drainage in the management of obstructive jaundice&#xD;
&#xD;
        -  EUS guided biliary drainage is associated with a reduced incidence of major (bile&#xD;
           peritonitis, procedure related mortality, hematobilia) and minor (abdominal pain,&#xD;
           prolonged hospital stay) complications.&#xD;
&#xD;
        -  EUS guided biliary drainage is more cost effective compared to percutaneous biliary&#xD;
           drainage&#xD;
&#xD;
      Aims of proposed research&#xD;
&#xD;
      Based on the current literature we propose a randomized pilot study assessing the following&#xD;
      specific end points&#xD;
&#xD;
        -  EUS biliary drainage is as effective as percutaneous biliary drainage in achieving&#xD;
           resolution of cholestasis&#xD;
&#xD;
        -  EUS biliary drainage is not associated with an increased risk of complications compared&#xD;
           to percutaneous biliary drainage.&#xD;
&#xD;
      Methodology&#xD;
&#xD;
      Study population. Patients with obstructive jaundice due to locally advanced/metastatic&#xD;
      malignancy with dilated intrahepatic bile ducts will be recruited from the department of&#xD;
      Gastroenterology and Hepatology at the University Hospital of Leuven.&#xD;
&#xD;
      This population will have failed ERCP or will be considered when ERCP is not possible due to&#xD;
      altered surgical anatomy.&#xD;
&#xD;
      Patients will be randomized to either PTC or EUS guided biliary drainage&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        -  Patients older than 18 years presenting with malignant obstructive jaundice&#xD;
&#xD;
        -  Locally advanced primary or metastatic malignancy involving the biliary tract&#xD;
&#xD;
        -  Patients in whom an ERCP have failed or where an ERCP is not possible due to surgically&#xD;
           altered anatomy (eg. Post-Whipple).&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
      • Resectable biliary tract malignancy with curative intent&#xD;
&#xD;
      Endoscopic method&#xD;
&#xD;
      Linear array endoscopic ultrasound (Pentax, Pentax Hitachi, Montvale, NJ) will be used to&#xD;
      identify the dilated left system. The Doppler mode was used to differentiate intrahepatic&#xD;
      bile ducts from portal and hepatic vein branches. A 19G needle (Echo-19, Cook, Limerick,&#xD;
      Ireland) will be used to puncture a peripherally located dilated segment 2 or 3 duct under&#xD;
      EUS guidance. Under fluoroscopic control a cholangiogram will be obtained and a standard&#xD;
      0.035 guide-wire (Hydra Jag wire, Boston Scientific, Natick, MA Boston Scientific) will be&#xD;
      advanced into the biliary system. Next a 6Fr cystotome (Endoflex, Voerde, Germany) will be&#xD;
      used to create a trans-gastric tract through the liver parenchyma to the dilated biliary&#xD;
      system. The guidewire will be manipulated across the stricture into the duodenal lumen. A&#xD;
      Hurricane biliary dilation balloon 4cm x4mm (Boston Scientific, Natick, MA Boston Scientific)&#xD;
      will be advanced through the tract and used to dilate the common bile duct stricture without&#xD;
      balloon dilation at the level of the gastric wall liver interface. A 10mmx 80mm uncovered&#xD;
      self expandable metallic stent (SEMS) will be advanced and deployed under fluoroscopy across&#xD;
      the papilla and past the duodenal obstruction when present.&#xD;
&#xD;
      In patients were the left ductal system is not dilated, biliary access will be obtained from&#xD;
      the duodenal bulb and a covered metal stent will be deployed in the stomach&#xD;
      (choledocho-enterostomy).&#xD;
&#xD;
      In patients with duodenal obstruction a Wallstent will be placed at the same session as part&#xD;
      of standard of care.&#xD;
&#xD;
      Novel research perspectives and expected outcomes&#xD;
&#xD;
        -  Our research will address a very difficult clinical problem in an unique way: comparing&#xD;
           the standard of care biliary drainage procedure (PTC) to EUS guided biliary drainage.&#xD;
&#xD;
        -  We expect to demonstrate that EUS guided biliary drainage is as effective as PTC&#xD;
&#xD;
        -  We also expect to show that EUS guided biliary drainage is associated with a reduced&#xD;
           incidence of complications and reduced hospital stay.&#xD;
&#xD;
      Study endpoints&#xD;
&#xD;
        -  Primary endpoints&#xD;
&#xD;
             -  Pain: Post-procedural pain as measured by visual analogue score (VAS) at 2, 24, and&#xD;
                72 hours following the procedures&#xD;
&#xD;
             -  Biochemical changes: Bilirubin decrease at 2 and 4 weeks&#xD;
&#xD;
        -  Secondary endpoints&#xD;
&#xD;
             -  Major complications including bile leak, bleeding, sepsis or death&#xD;
&#xD;
             -  Duration of procedures in minutes&#xD;
&#xD;
             -  Length of ICU and hospital stay&#xD;
&#xD;
             -  Minor complications&#xD;
&#xD;
      Statistics power calculations It is assumed that 50% of the patients will experience&#xD;
      prolonged pain after PTC defined as pain lasting more than 48 hours and requiring analgesics.&#xD;
      48 patients in total (24 per group) are then needed to detect with 80% power a difference&#xD;
      with EUS, expecting 10% of the patients having prolonged pain after EUS. The sample size&#xD;
      calculation is based on a two-sided Fisher's Exact test (with alpha=5%). To compensate for&#xD;
      potential dropout, 7 additional patients in total will be recruited. Therefor the sample size&#xD;
      will comprise of 55 patients. Exact 95% confidence intervals will be calculated for the&#xD;
      proportion major complications in both groups. Proportions will be compared using a Fisher's&#xD;
      Exact test. A Mann-Whitney U test will be used to compare the actual VAS scores and changes&#xD;
      in VAS scores between groups. A log-rank test will be used to compare the length of hospital&#xD;
      stay (LOS), censoring potential deceased patients at a value exceeding the highest observed&#xD;
      LOS.&#xD;
&#xD;
      P-values smaller than 0.05 will be considered significant. Statistical analyses will be&#xD;
      performed using SAS software, version 9.2 of the SAS System for Windowsld be given when&#xD;
      defining the endpoints.&#xD;
&#xD;
      Investigators:&#xD;
&#xD;
      Department of Internal Medicine, Division of Hepatology: Prof. Frederik Nevens, Prof. Werner&#xD;
      van Steenbergen, Prof. Chris Verslype, Prof. Wim Laleman, Prof. David Cassiman, Prof. Schalk&#xD;
      van der Merwe&#xD;
&#xD;
      Department of Interventional radiology:&#xD;
&#xD;
      Prof. Geert Maleux, Dr. Sam Heye, Dr. Johan Vaninbroukx&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">July 2014</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain: Post-procedural pain as measured by visual analogue score (VAS) at 2, 24, and 72 hours following the procedures</measure>
    <time_frame>72 hours</time_frame>
    <description>- Primary endpoints&#xD;
Pain: Post-procedural pain as measured by visual analogue score (VAS) at 2, 24, and 72 hours following the procedures&#xD;
Biochemical changes: Bilirubin decrease at 2 and 4 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major complications including bile leak, bleeding, sepsis or death</measure>
    <time_frame>Participants will be followed for the duration of their hospital stay and for up to 4 weeks. In addition patients will be followed up to death or for a maximum period of 1 year following the procedure</time_frame>
    <description>- Secondary endpoints&#xD;
Major complications including bile leak, bleeding, sepsis or death&#xD;
Duration of procedures&#xD;
Length of ICU stay&#xD;
Minor complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Malignant Biliary Obstruction</condition>
  <arm_group>
    <arm_group_label>Percutaneous Transhepatic cholangiography</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Endoscopic Ultrasound guided biliary drainage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous transhepatic cholangiography vs. endoscopic biliary drainage</intervention_name>
    <description>Percutaneous transhepatic cholangiography biliary drainage is compared tot endoscopic biliary drainage in the management of malignant biliary obstruction not amenable to ERCP</description>
    <arm_group_label>Endoscopic Ultrasound guided biliary drainage</arm_group_label>
    <arm_group_label>Percutaneous Transhepatic cholangiography</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years presenting with malignant obstructive jaundice&#xD;
&#xD;
          -  Locally advanced primary or metastatic malignancy involving the biliary tract&#xD;
&#xD;
          -  Patients in whom an ERCP have failed or where an ERCP is not possible due to&#xD;
             surgically altered anatomy (eg. Post-Whipple).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Resectable biliary tract malignancy with curative intent&#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>Schalk van der Merwe, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Schalk van der Merwe, MD, PhD</last_name>
    <phone>+32 16 34 42 99</phone>
    <email>schalk.vandermerwe@uzleuven.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Schalk van der Merwe, MD, PhD</last_name>
      <phone>+32 16 34 42 99</phone>
      <email>schalk.vandermerwe@uzleuven.be</email>
    </contact>
    <contact_backup>
      <last_name>Frederik Nevens, MD, PhD</last_name>
      <phone>+32 16 34 42 99</phone>
      <email>frederik.nevens@uzleuven.be</email>
    </contact_backup>
    <investigator>
      <last_name>Frederik Nevens, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Werner Van Steenbergen, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chris Verslype, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>David Cassiman, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wim Laleman, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Geert Maleux, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Schalk van der Merwe, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>July 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>June 12, 2013</last_update_submitted>
  <last_update_submitted_qc>June 12, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 13, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cholestasis</keyword>
  <keyword>Malignancy</keyword>
  <keyword>ERCP</keyword>
  <keyword>PTC</keyword>
  <keyword>EUS-BD</keyword>
  <!-- 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/NCT01686425
org study id: ML8383
nct id: NCT01686425
lead sponsor: 
has dmc: No
Patients with obstructive jaundice due to locally advanced/metastatic malignancy with dilated
      intrahepatic bile ducts will be recruited from the department of Gastroenterology and
      Hepatology at the University Hospital of Leuven.

      This population will have failed ERCP or will be considered when ERCP is not possible due to
      altered surgical anatomy.

      Patients will be randomized to either PTC or EUS guided biliary drainage
Background:

      Advanced biliary tract malignancy complicated by obstructive jaundice has been traditionally
      managed by palliative stent placement at ERCP. In 3-12% of patients with advanced disease
      tumour involvement of the small bowel or peri-ampullary region may preclude the use of ERCP
      necessitating percutaneous transhepatic biliary drainage (PTBD) or surgery1. However these
      techniques have been associated with high complication rates and significant morbidity2. PTBD
      necessitates traversing the parietal and visceral peritoneum causing a potential for a bile
      leak and bleeding into the peritoneal cavity. This procedure is also associated with
      significant pain, lengthy hospital stays and an overall reduction in quality of life, and
      even procedure related mortality. Indeed the Society of Interventional Radiology (SIR)
      quality improvements guidelines established the procedural risk of severe major complications
      including sepsis, bleeding and procedural related death at 2.5% and less severe complications
      including pain and prolonged hospital admissions at 20%.

      In recent years various groups have described endoscopic ultrasound guided access of the left
      system allowing placement of metal or plastic stents either across the distal stricture or
      deploying the stent in the stomach (hepatico-gastrostomy), with high technical success3.
      Retrograde cannulation normally performed from the duodenal bulb allows access to the biliary
      tract above a malignant stricture with the intent to either pass a guide wire through the
      papilla and then perform a rendezvous procedure, or the placement of a covered metal stent
      into the stomach (choledochoenterostomy)10. Cannulation of a dilated segment 2 or 3 sectoral
      duct is also possible from the proximal stomach where the endoscopist performs all procedures
      in an antegrade fashion5. Currently these procedures are selectively performed in centres by
      expert endoscopists from mainly tertiary care academic expert centres including in Leuven.
      Collectively EUS biliary drainage is technically successful in 75-92% of cases, however
      reports of bile leaking and peritonitis have been described5.

      Various obstacles however still exist to extend the general applicability of this technique
      outside expert centres. Firstly, no randomized control trials exist comparing the safety and
      efficacy of EUS biliary access to Percutaneous Transhepatic Cholangiography (PTC). Secondly,
      current endoscopic techniques utilize standard endoscopic accessories not specifically
      developed to be utilized within the biliary system when advanced through the gastric wall.
      Thirdly, specific EUS strategies are needed to prevent or reduce complications associated
      with percutaneous approaches.

      Concept and preliminary experimental data

      Hypothesis

      Based on the literature we hypothesize that:

        -  Endoscopic ultrasound guided biliary drainage is more effective than percutaneous
           biliary drainage in the management of obstructive jaundice

        -  EUS guided biliary drainage is associated with a reduced incidence of major (bile
           peritonitis, procedure related mortality, hematobilia) and minor (abdominal pain,
           prolonged hospital stay) complications.

        -  EUS guided biliary drainage is more cost effective compared to percutaneous biliary
           drainage

      Aims of proposed research

      Based on the current literature we propose a randomized pilot study assessing the following
      specific end points

        -  EUS biliary drainage is as effective as percutaneous biliary drainage in achieving
           resolution of cholestasis

        -  EUS biliary drainage is not associated with an increased risk of complications compared
           to percutaneous biliary drainage.

      Methodology

      Study population. Patients with obstructive jaundice due to locally advanced/metastatic
      malignancy with dilated intrahepatic bile ducts will be recruited from the department of
      Gastroenterology and Hepatology at the University Hospital of Leuven.

      This population will have failed ERCP or will be considered when ERCP is not possible due to
      altered surgical anatomy.

      Patients will be randomized to either PTC or EUS guided biliary drainage

      Inclusion criteria:

        -  Patients older than 18 years presenting with malignant obstructive jaundice

        -  Locally advanced primary or metastatic malignancy involving the biliary tract

        -  Patients in whom an ERCP have failed or where an ERCP is not possible due to surgically
           altered anatomy (eg. Post-Whipple).

      Exclusion criteria:

      • Resectable biliary tract malignancy with curative intent

      Endoscopic method

      Linear array endoscopic ultrasound (Pentax, Pentax Hitachi, Montvale, NJ) will be used to
      identify the dilated left system. The Doppler mode was used to differentiate intrahepatic
      bile ducts from portal and hepatic vein branches. A 19G needle (Echo-19, Cook, Limerick,
      Ireland) will be used to puncture a peripherally located dilated segment 2 or 3 duct under
      EUS guidance. Under fluoroscopic control a cholangiogram will be obtained and a standard
      0.035 guide-wire (Hydra Jag wire, Boston Scientific, Natick, MA Boston Scientific) will be
      advanced into the biliary system. Next a 6Fr cystotome (Endoflex, Voerde, Germany) will be
      used to create a trans-gastric tract through the liver parenchyma to the dilated biliary
      system. The guidewire will be manipulated across the stricture into the duodenal lumen. A
      Hurricane biliary dilation balloon 4cm x4mm (Boston Scientific, Natick, MA Boston Scientific)
      will be advanced through the tract and used to dilate the common bile duct stricture without
      balloon dilation at the level of the gastric wall liver interface. A 10mmx 80mm uncovered
      self expandable metallic stent (SEMS) will be advanced and deployed under fluoroscopy across
      the papilla and past the duodenal obstruction when present.

      In patients were the left ductal system is not dilated, biliary access will be obtained from
      the duodenal bulb and a covered metal stent will be deployed in the stomach
      (choledocho-enterostomy).

      In patients with duodenal obstruction a Wallstent will be placed at the same session as part
      of standard of care.

      Novel research perspectives and expected outcomes

        -  Our research will address a very difficult clinical problem in an unique way: comparing
           the standard of care biliary drainage procedure (PTC) to EUS guided biliary drainage.

        -  We expect to demonstrate that EUS guided biliary drainage is as effective as PTC

        -  We also expect to show that EUS guided biliary drainage is associated with a reduced
           incidence of complications and reduced hospital stay.

      Study endpoints

        -  Primary endpoints

             -  Pain: Post-procedural pain as measured by visual analogue score (VAS) at 2, 24, and
                72 hours following the procedures

             -  Biochemical changes: Bilirubin decrease at 2 and 4 weeks

        -  Secondary endpoints

             -  Major complications including bile leak, bleeding, sepsis or death

             -  Duration of procedures in minutes

             -  Length of ICU and hospital stay

             -  Minor complications

      Statistics power calculations It is assumed that 50% of the patients will experience
      prolonged pain after PTC defined as pain lasting more than 48 hours and requiring analgesics.
      48 patients in total (24 per group) are then needed to detect with 80% power a difference
      with EUS, expecting 10% of the patients having prolonged pain after EUS. The sample size
      calculation is based on a two-sided Fisher's Exact test (with alpha=5%). To compensate for
      potential dropout, 7 additional patients in total will be recruited. Therefor the sample size
      will comprise of 55 patients. Exact 95% confidence intervals will be calculated for the
      proportion major complications in both groups. Proportions will be compared using a Fisher's
      Exact test. A Mann-Whitney U test will be used to compare the actual VAS scores and changes
      in VAS scores between groups. A log-rank test will be used to compare the length of hospital
      stay (LOS), censoring potential deceased patients at a value exceeding the highest observed
      LOS.

      P-values smaller than 0.05 will be considered significant. Statistical analyses will be
      performed using SAS software, version 9.2 of the SAS System for Windowsld be given when
      defining the endpoints.

      Investigators:

      Department of Internal Medicine, Division of Hepatology: Prof. Frederik Nevens, Prof. Werner
      van Steenbergen, Prof. Chris Verslype, Prof. Wim Laleman, Prof. David Cassiman, Prof. Schalk
      van der Merwe

      Department of Interventional radiology:

      Prof. Geert Maleux, Dr. Sam Heye, Dr. Johan Vaninbroukx
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain: Post-procedural pain as measured by visual analogue score (VAS) at 2, 24, and 72 hours following the procedures
time frame: 72 hours
description: - Primary endpoints
Pain: Post-procedural pain as measured by visual analogue score (VAS) at 2, 24, and 72 hours following the procedures
Biochemical changes: Bilirubin decrease at 2 and 4 weeks
measure: Major complications including bile leak, bleeding, sepsis or death
time frame: Participants will be followed for the duration of their hospital stay and for up to 4 weeks. In addition patients will be followed up to death or for a maximum period of 1 year following the procedure
description: - Secondary endpoints
Major complications including bile leak, bleeding, sepsis or death
Duration of procedures
Length of ICU stay
Minor complications
arm group label: Percutaneous Transhepatic cholangiography
arm group type: Active Comparator
arm group label: Endoscopic Ultrasound guided biliary drainage
arm group type: Active Comparator
intervention type: Procedure
intervention name: Percutaneous transhepatic cholangiography vs. endoscopic biliary drainage
description: Percutaneous transhepatic cholangiography biliary drainage is compared tot endoscopic biliary drainage in the management of malignant biliary obstruction not amenable to ERCP
arm group label: Endoscopic Ultrasound guided biliary drainage
arm group label: Percutaneous Transhepatic cholangiography
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Schalk van der Merwe, MD, PhD
role: Principal Investigator
affiliation: UZ Leuven
last name: Schalk van der Merwe, MD, PhD
phone: +32 16 34 42 99
email: schalk.vandermerwe@uzleuven.be
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Belgium
responsible party type: Sponsor