<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/NCT01721174</url>
  </required_header>
  <id_info>
    <org_study_id>CRE 2012.153</org_study_id>
    <nct_id>NCT01721174</nct_id>
  </id_info>
  <brief_title>Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures</brief_title>
  <official_title>A Randomized Controlled Trial of Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Malignant bile duct obstruction is a common sequela of pancreatic cancers or distal bile duct&#xD;
      cancers, and its development can hinder the use of chemotherapy, decrease patient quality of&#xD;
      life, and decrease survival. To relieve obstructive jaundice as a result of the obstruction,&#xD;
      endoscopic stent placement is usually required. The use self-expandable metal stents (SEMSs)&#xD;
      have been shown to result in a longer patency times as compared with plastic stents. However,&#xD;
      despite improvements in materials and stent design, stent obstruction still occurs in 13% to&#xD;
      44% of the patients. Tumor in-growth is the most common mechanism of stent obstruction.&#xD;
&#xD;
      Recently, the use of endoscopic biliary radiofrequency ablation (EBRFA) have been described&#xD;
      in patients suffering from inoperable malignant distal common bile duct (CBD) obstruction.&#xD;
      The procedure uses heat energy to cause local tumour tissue death, resulting in re-opening of&#xD;
      the bile duct lumen. The procedure has the potential of reducing the rate of stent&#xD;
      obstruction after SEMS and also prolonging survival. The safety profile appears to be&#xD;
      comparable that of placement of SEMS alone without added complications (&lt;10%). The aim of the&#xD;
      current study is to compare the efficacy of EBRFA with the addition of SEMS to SEMS alone in&#xD;
      a randomized controlled trial.We hypothesize that the application of EBRFA can reduce&#xD;
      recurrent biliary obstruction after SEMS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Poor recruitment&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Stent patency rate</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events</measure>
    <time_frame>30 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unscheduled readmission rates</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Cholangiocarcinoma</condition>
  <arm_group>
    <arm_group_label>SEMS only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the length of the biliary stricture, diameter, and position. An uncovered self expanding metallic stent (SEMS) would be inserted to bypass the site of narrowing (Niti-S biliary uncovered metallic stent; Taewoong Medical, Gimpo City, Korea)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EBRFA and SEMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the length of the biliary stricture, diameter, and position. The radiofrequency ablation (EBRFA) catheter would be placed under fluoroscopic guidance across the biliary stricture. The Habib EndoHPB (EMcision UK, London, United Kingdom) radiofrequency ablation catheter with energy delivered by an RFA generator would be used to apply RFA to the entire length of the stricture, sequential applications would be applied to complete treatment throughout the length of the stricture without significant overlap of treated areas. Patients would undergo 2 sessions of EBRFA 2 weeks apart. A plastic stent would be inserted in between the 2 sessions. An uncovered SEMSs (Niti-S biliary uncovered metallic stent; Taewoong Medical, Gimpo City, Korea) would be placed after the second EBRFA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SEMS only</intervention_name>
    <description>The SEMS (Niti-S biliary uncovered metallic stent; Taewoong Medical, Korea) would be placed.</description>
    <arm_group_label>SEMS only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>EBRFA and SEMS</intervention_name>
    <description>The radiofrequency ablation (RFA) catheter would be placed under fluoroscopic guidance across the biliary stricture. The Habib EndoHPB (EMcision UK, London, United Kingdom) radiofrequency ablation catheter is a bipolar RFA probe that is 8F (2.6 mm), 1.8 m long, compatible with standard (3.2-mm working channel) side-viewing endoscopes, and passes over 0.035-inch guidewires. The catheter has 2 ring electrodes 8 mm apart with the distal electrode 5 mm from the leading edge, providing local coagulative necrosis over a 2.5-cm length. Depending on the length of the stricture, sequential applications would be applied to complete treatment throughout the length of the stricture without significant overlap of treated areas. An uncovered SEMSs (Niti-S biliary uncovered metallic stent; Taewoong Medical, Gimpo City, Korea) would be placed after 2 sessions of EBRFA.</description>
    <arm_group_label>EBRFA and SEMS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years old with informed consent&#xD;
&#xD;
          2. Histologically (preferred) or radiologically confirmed distal malignant bile duct&#xD;
             tumors&#xD;
&#xD;
          3. Inoperability by staging, comorbidities or patient wishes&#xD;
&#xD;
          4. Distal tumors 2cm away from the portal hilum&#xD;
&#xD;
          5. Bilirubin &gt; 50umol/L at diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Periampullary tumours&#xD;
&#xD;
          2. Multiple hepatic metastases with significant blockage of one or more liver segments&#xD;
             (if no segment blockage, metastasis is not an exclusion criteria)&#xD;
&#xD;
          3. Presence of main portal vein thrombosis&#xD;
&#xD;
          4. Prior SEMS placement&#xD;
&#xD;
          5. Prior Billroth II or roux-en Y reconstruction&#xD;
&#xD;
          6. History of bleeding disorder or use of anticoagulation&#xD;
&#xD;
          7. Child's B/C cirrhosis&#xD;
&#xD;
          8. Pregnancy&#xD;
&#xD;
          9. Performance status ECOG ≥3 (confined to bed / chair &gt; 50% waking hours)&#xD;
&#xD;
         10. Presence of other malignancy&#xD;
&#xD;
         11. Presence of gastric outlet obstruction&#xD;
&#xD;
         12. Life expectancy &lt; 3months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Prince of Wales Hospital, Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Steel AW, Postgate AJ, Khorsandi S, Nicholls J, Jiao L, Vlavianos P, Habib N, Westaby D. Endoscopically applied radiofrequency ablation appears to be safe in the treatment of malignant biliary obstruction. Gastrointest Endosc. 2011 Jan;73(1):149-53. doi: 10.1016/j.gie.2010.09.031.</citation>
    <PMID>21184881</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>January 24, 2018</last_update_submitted>
  <last_update_submitted_qc>January 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2018</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>Anthony Teoh</investigator_full_name>
    <investigator_title>Honorary Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Pancreatic cancer</keyword>
  <keyword>Cholangiocarcinoma</keyword>
  <keyword>Endoscopic radiofrequency ablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Cholangiocarcinoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT01721174
org study id: CRE 2012.153
nct id: NCT01721174
lead sponsor: 
has dmc: No
Malignant bile duct obstruction is a common sequela of pancreatic cancers or distal bile duct
      cancers, and its development can hinder the use of chemotherapy, decrease patient quality of
      life, and decrease survival. To relieve obstructive jaundice as a result of the obstruction,
      endoscopic stent placement is usually required. The use self-expandable metal stents (SEMSs)
      have been shown to result in a longer patency times as compared with plastic stents. However,
      despite improvements in materials and stent design, stent obstruction still occurs in 13% to
      44% of the patients. Tumor in-growth is the most common mechanism of stent obstruction.

      Recently, the use of endoscopic biliary radiofrequency ablation (EBRFA) have been described
      in patients suffering from inoperable malignant distal common bile duct (CBD) obstruction.
      The procedure uses heat energy to cause local tumour tissue death, resulting in re-opening of
      the bile duct lumen. The procedure has the potential of reducing the rate of stent
      obstruction after SEMS and also prolonging survival. The safety profile appears to be
      comparable that of placement of SEMS alone without added complications (<10%). The aim of the
      current study is to compare the efficacy of EBRFA with the addition of SEMS to SEMS alone in
      a randomized controlled trial.We hypothesize that the application of EBRFA can reduce
      recurrent biliary obstruction after SEMS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Stent patency rate
time frame: 6 months
measure: Overall survival
time frame: 3 years
measure: Serious adverse events
time frame: 30 day
measure: Unscheduled readmission rates
time frame: 1 year
arm group label: SEMS only
arm group type: Active Comparator
description: Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the length of the biliary stricture, diameter, and position. An uncovered self expanding metallic stent (SEMS) would be inserted to bypass the site of narrowing (Niti-S biliary uncovered metallic stent; Taewoong Medical, Gimpo City, Korea)
arm group label: EBRFA and SEMS
arm group type: Active Comparator
description: Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the length of the biliary stricture, diameter, and position. The radiofrequency ablation (EBRFA) catheter would be placed under fluoroscopic guidance across the biliary stricture. The Habib EndoHPB (EMcision UK, London, United Kingdom) radiofrequency ablation catheter with energy delivered by an RFA generator would be used to apply RFA to the entire length of the stricture, sequential applications would be applied to complete treatment throughout the length of the stricture without significant overlap of treated areas. Patients would undergo 2 sessions of EBRFA 2 weeks apart. A plastic stent would be inserted in between the 2 sessions. An uncovered SEMSs (Niti-S biliary uncovered metallic stent; Taewoong Medical, Gimpo City, Korea) would be placed after the second EBRFA.
intervention type: Procedure
intervention name: SEMS only
description: The SEMS (Niti-S biliary uncovered metallic stent; Taewoong Medical, Korea) would be placed.
arm group label: SEMS only
intervention type: Procedure
intervention name: EBRFA and SEMS
description: The radiofrequency ablation (RFA) catheter would be placed under fluoroscopic guidance across the biliary stricture. The Habib EndoHPB (EMcision UK, London, United Kingdom) radiofrequency ablation catheter is a bipolar RFA probe that is 8F (2.6 mm), 1.8 m long, compatible with standard (3.2-mm working channel) side-viewing endoscopes, and passes over 0.035-inch guidewires. The catheter has 2 ring electrodes 8 mm apart with the distal electrode 5 mm from the leading edge, providing local coagulative necrosis over a 2.5-cm length. Depending on the length of the stricture, sequential applications would be applied to complete treatment throughout the length of the stricture without significant overlap of treated areas. An uncovered SEMSs (Niti-S biliary uncovered metallic stent; Taewoong Medical, Gimpo City, Korea) would be placed after 2 sessions of EBRFA.
arm group label: EBRFA and SEMS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Hong Kong
citation: Steel AW, Postgate AJ, Khorsandi S, Nicholls J, Jiao L, Vlavianos P, Habib N, Westaby D. Endoscopically applied radiofrequency ablation appears to be safe in the treatment of malignant biliary obstruction. Gastrointest Endosc. 2011 Jan;73(1):149-53. doi: 10.1016/j.gie.2010.09.031.
PMID: 21184881
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Anthony Teoh
investigator title: Honorary Assistant Professor
mesh term: Pancreatic Neoplasms
mesh term: Cholangiocarcinoma