<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/NCT03772756</url>
  </required_header>
  <id_info>
    <org_study_id>2018-139-01</org_study_id>
    <nct_id>NCT03772756</nct_id>
  </id_info>
  <brief_title>EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma</brief_title>
  <official_title>Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Unresectable Pancreatic Adenocarcinoma - a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First People's Hospital of Hangzhou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First People's Hospital of Hangzhou</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>
      the study evaluate the efficacy and safety of EUS-RFA using Habib EUS-RFA catheter with a&#xD;
      prospective randomised trial in patients with inoperable PDAC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The five year survival for pancreatic ductal adenocarcinoma (PDAC) is less than 5% in spite&#xD;
      of the advances in management of cancers in the last few decades. Endobiliary application of&#xD;
      radiofrequency ablation (RFA) has been developed in our unit and used in patients with&#xD;
      unresectable bile duct and pancreatic head adenocarcinomas presenting with biliary&#xD;
      obstruction. Various techniques of EUS-guided tumour ablation have been described, including&#xD;
      RF ablation, photodynamic therapy, laser ablation, and ethanol injection. Endoscopic&#xD;
      ultrasound guided RFA (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter through a&#xD;
      19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis&#xD;
      .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">August 16, 2021</completion_date>
  <primary_completion_date type="Actual">August 16, 2021</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in tumour size as measured on EUS and or CT</measure>
    <time_frame>60 days</time_frame>
    <description>The tumor size was compared before and after 60 days EUS-RFA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in serum levels of Ca 19-9</measure>
    <time_frame>60 days</time_frame>
    <description>Serum levels of Ca 19-9 was compared before and after 60 days EUS-RFA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Survival rate 6 months after EUS-RFA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Survival rate 12 months after EUS-RFA</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Pancreatic Adenocarcinoma Non-resectable</condition>
  <arm_group>
    <arm_group_label>EUS-RFA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in EUS-RFA group will undergo endoscopic ultrasound guided radiofrequency ablation(EUS-RFA ) and chemoradiotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the control group will receive chemoradiotherapy only</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic ultrasound guided radiofrequency ablation</intervention_name>
    <description>Endoscopic ultrasound guided radiofrequency ablation （EUS-RFA） will be done in 3 different sessions with 2 weeks interval between each session on Day 1, Day 15 and Day 30. Each session will involve multiple applications of EUS-RFA (up to 10) with RF setting of 25 Watts over 90 seconds for each application.</description>
    <arm_group_label>EUS-RFA group</arm_group_label>
    <other_name>EUS-RFA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>chemoradiotherapy</intervention_name>
    <description>Receive chemoradiotherapy</description>
    <arm_group_label>EUS-RFA group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients in the age group 20 to 80 years&#xD;
&#xD;
          -  A cytological or histological diagnosis of inoperable PDAC based on multidisciplinary&#xD;
             review of cross sectional imaging and cytology or histology results.&#xD;
&#xD;
          -  Patients who have been deemed unfit for surgical resection of the PDAC subjects who&#xD;
             are fit for surgical resection but have declined surgery will also be considered for&#xD;
             the study&#xD;
&#xD;
          -  PDAC patients presenting with jaundice to be considered after a successful biliary&#xD;
             drainage&#xD;
&#xD;
          -  Patients ought to be fit enough to be considered for the study (ECOG performance&#xD;
             status 0, 1 or 2)&#xD;
&#xD;
          -  Patients capable of giving informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  ECOG performance status 3 or 4&#xD;
&#xD;
          -  Life expectancy less than 3 months&#xD;
&#xD;
          -  Patients with distant metastases or malignant ascites&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaofeng Zhang</last_name>
    <role>Principal Investigator</role>
    <affiliation>First People's Hospital of Hangzhou</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jianfeng Yang</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hangzhou First People's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>31006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Gaidhane M, Smith I, Ellen K, Gatesman J, Habib N, Foley P, Moskaluk C, Kahaleh M. Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA) of the Pancreas in a Porcine Model. Gastroenterol Res Pract. 2012;2012:431451. doi: 10.1155/2012/431451. Epub 2012 Sep 20.</citation>
    <PMID>23049547</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>August 27, 2021</last_update_submitted>
  <last_update_submitted_qc>August 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First People's Hospital of Hangzhou</investigator_affiliation>
    <investigator_full_name>Jianfeng Yang</investigator_full_name>
    <investigator_title>Associate director of gastroenterology department</investigator_title>
  </responsible_party>
  <keyword>pancreatic adenocarcinoma</keyword>
  <keyword>radiofrequency ablation</keyword>
  <keyword>Endoscopic ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</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/NCT03772756
org study id: 2018-139-01
nct id: NCT03772756
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
the study evaluate the efficacy and safety of EUS-RFA using Habib EUS-RFA catheter with a
      prospective randomised trial in patients with inoperable PDAC.
The five year survival for pancreatic ductal adenocarcinoma (PDAC) is less than 5% in spite
      of the advances in management of cancers in the last few decades. Endobiliary application of
      radiofrequency ablation (RFA) has been developed in our unit and used in patients with
      unresectable bile duct and pancreatic head adenocarcinomas presenting with biliary
      obstruction. Various techniques of EUS-guided tumour ablation have been described, including
      RF ablation, photodynamic therapy, laser ablation, and ethanol injection. Endoscopic
      ultrasound guided RFA (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter through a
      19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis
      .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in tumour size as measured on EUS and or CT
time frame: 60 days
description: The tumor size was compared before and after 60 days EUS-RFA
measure: Change in serum levels of Ca 19-9
time frame: 60 days
description: Serum levels of Ca 19-9 was compared before and after 60 days EUS-RFA
measure: Overall survival at 6 months
time frame: 6 months
description: Survival rate 6 months after EUS-RFA
measure: Overall survival at 12 months
time frame: 12 months
description: Survival rate 12 months after EUS-RFA
arm group label: EUS-RFA group
arm group type: Experimental
description: Patients in EUS-RFA group will undergo endoscopic ultrasound guided radiofrequency ablation(EUS-RFA ) and chemoradiotherapy
arm group label: control group
arm group type: Active Comparator
description: the control group will receive chemoradiotherapy only
intervention type: Procedure
intervention name: Endoscopic ultrasound guided radiofrequency ablation
description: Endoscopic ultrasound guided radiofrequency ablation （EUS-RFA） will be done in 3 different sessions with 2 weeks interval between each session on Day 1, Day 15 and Day 30. Each session will involve multiple applications of EUS-RFA (up to 10) with RF setting of 25 Watts over 90 seconds for each application.
arm group label: EUS-RFA group
other name: EUS-RFA
intervention type: Radiation
intervention name: chemoradiotherapy
description: Receive chemoradiotherapy
arm group label: EUS-RFA group
arm group label: control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xiaofeng Zhang
role: Principal Investigator
affiliation: First People's Hospital of Hangzhou
facility: 
facility: 
country: China
citation: Gaidhane M, Smith I, Ellen K, Gatesman J, Habib N, Foley P, Moskaluk C, Kahaleh M. Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA) of the Pancreas in a Porcine Model. Gastroenterol Res Pract. 2012;2012:431451. doi: 10.1155/2012/431451. Epub 2012 Sep 20.
PMID: 23049547
responsible party type: Principal Investigator
investigator affiliation: First People's Hospital of Hangzhou
investigator full name: Jianfeng Yang
investigator title: Associate director of gastroenterology department
mesh term: Adenocarcinoma