<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/NCT04472468</url>
  </required_header>
  <id_info>
    <org_study_id>C18-004</org_study_id>
    <nct_id>NCT04472468</nct_id>
  </id_info>
  <brief_title>Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)</brief_title>
  <acronym>PMAP</acronym>
  <official_title>Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP) - A Randomized Study</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>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>
      Pericardial effusion is a common complication in patients with metastatic malignancy. While&#xD;
      pericardiocentesis provide effective relieve from life-threatening situation such as cardiac&#xD;
      tamponade, recurrence of pericardial effusion after pericardiocentesis is common. We&#xD;
      hypothesize that percutaneous balloon pericardiotomy in addition to standard&#xD;
      pericardiocentesis with prolonged drainage can prevent pericardial effusion recurrence in&#xD;
      patients with malignant pericardial effusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pericardial effusion is a common complication in patients with metastatic malignancy with an&#xD;
      incidence as high as 21%. The occurrence of malignant pericardial effusion significantly&#xD;
      impacts on patient's survival and quality of life. While pericardiocentesis provide effective&#xD;
      relieve from life-threatening situation such as cardiac tamponade, recurrence of pericardial&#xD;
      effusion after pericardiocentesis is common and occurs in as high as 31% of patients.&#xD;
      Retrospective data has shown that prolonged pericardial drainage might reduce the recurrence&#xD;
      rate but at the cost of increased risk of infection and prolonged hospital stay. Surgical&#xD;
      pericardiotomy was used in the past but was not shown to reduce recurrence over prolonged&#xD;
      pericardial drainage and is associated with a higher rate of complications. Surgical&#xD;
      pericardial window creation via a mini-thoracotomy might be an effective treatment and can be&#xD;
      considered in patient with pericardial tamponade. The safety and feasibility of Percutaneous&#xD;
      Balloon pericardiotomy (PBP) has been first described 1993 and has been shown to be an&#xD;
      alternative treatment for patient with malignant pericardial effusion. However, no data is&#xD;
      available on the efficacy of PBP in reducing the recurrence of pericardial effusion, in&#xD;
      comparison with standard pericardiocentesis with prolonged drainage. We aim to perform a&#xD;
      single centre, randomized, prospective, open label controlled pragmatic trial to compare&#xD;
      percutaneous balloon pericardiotomy (treatment) to standard pericardiocentesis with prolonged&#xD;
      drainage (control) in preventing pericardial effusion recurrence in patients with malignant&#xD;
      pericardial effusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2024</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>Single Group Assignment</intervention_model>
    <intervention_model_description>single centre, randomized, prospective, open label controlled pragmatic trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pericardial effusion recurrence</measure>
    <time_frame>3 months</time_frame>
    <description>Recurrence of pericardial effusion after index procedure, defined as development of moderate or more pericardial effusion (&gt;10mm) on follow-up imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Procedural related complications</measure>
    <time_frame>Immediate after intervention</time_frame>
    <description>Procedural related complications including procedural related death, need for urgent surgical intervention, pleural effusion and pneumothorax</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>3 months</time_frame>
    <description>overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pericardial effusion free survival</measure>
    <time_frame>3 months</time_frame>
    <description>survival without recurrence of pericardial effusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac tamponade</measure>
    <time_frame>3 months</time_frame>
    <description>Occurrence of cardiac tamponade as defined by echocardiographic finding of any of the following: 1. diastolic collapse of the right atrium, 2. Diastolic collapse of the right ventricle, 3. respiratory variation of the mitral E' velocity &gt; 25% or tricuspid E' velocity &gt;40%, 4. dilated IVC &gt;20mm and &lt;50% respiratory reduction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measure (using Functional Assessment of Cancer Therapy - General version (Chinese version)).</measure>
    <time_frame>3 months</time_frame>
    <description>27 items self-administered questionnaire examining the impact of a cancer related therapy on 4 domains of life using a 5-points scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pericardial drain indwelling time</measure>
    <time_frame>during index procedure</time_frame>
    <description>Pericardial drain indwelling time at index procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catheter tract tumor seeding</measure>
    <time_frame>3 months</time_frame>
    <description>Evidence of tumour seeding in catheter tract or extra-pericardial cavity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ascites/Pleural effusion</measure>
    <time_frame>3 months</time_frame>
    <description>Occurrence of ascites and pleural effusion by either clinical examination or on radiological investigation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Pericardial Effusion Malignant</condition>
  <arm_group>
    <arm_group_label>Treatment (pericardiotomy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient in this arm will receive balloon pericardiotomy before insertion of pericardiocentesis.&#xD;
An 20mm over-the-wire ultra-non-compliant Percutaneous Transluminal Angioplasty Balloon is used to dilate the pericardium.&#xD;
Success of balloon pericardiotomy is confirmed by full inflation of the balloon which is confirmed on two orthogonal projections.&#xD;
Standard pericardiocentesis with prolonged drainage is performed afterwards.&#xD;
Pericardial drain is removed when output is less than 100cc/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (standard pericardiocentesis)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard pericardiocentesis procedure is performed using standard pigtail pericardial drain. - Pericardial fluid is then tapped until dry on table.&#xD;
Pericardial drain is removed when output is less than 100cc/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous Balloon Pericardiotomy</intervention_name>
    <description>Subxiphoid approach under fluoroscopic guidance is used.&#xD;
An 20mm over-the-wire ultra-non-compliant Percutaneous Transluminal Angioplasty Balloon is advanced into the pericardial space.&#xD;
Success of balloon pericardiotomy is confirmed by full inflation of the balloon which is confirmed on two orthogonal projections.</description>
    <arm_group_label>Treatment (pericardiotomy)</arm_group_label>
    <other_name>balloon pericardiotomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with confirmed active malignancy AND,&#xD;
&#xD;
          -  Presence of at least moderate (&gt;10cm) pericardial effusion on CT or Echocardiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to give an informed consent,&#xD;
&#xD;
          -  Previous history of open-heart surgery&#xD;
&#xD;
          -  Previous history of pericardial window or pericardial instillation of sclerosing&#xD;
             therapy.&#xD;
&#xD;
          -  Scheduled thoracic or cardiac surgery within the next 3 months&#xD;
&#xD;
          -  Patients with contraindications for endovascular procedure such as disseminated&#xD;
             intravascular coagulopathy or significant ongoing bleeding tendency, and systemic&#xD;
             septicaemia.&#xD;
&#xD;
          -  Patient with small or loculated pericardial effusion that is not accessible by&#xD;
             subxiphoid approach.&#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_contact>
    <last_name>GuangMing Tan, MD</last_name>
    <phone>85255699658</phone>
    <email>gtan@cuhk.edu.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daniel Xu</last_name>
    <phone>852 7382 1748</phone>
    <email>xjldaniel@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <state>Shatin</state>
        <zip>0000</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>GuangMing Tan</last_name>
      <phone>85255699658</phone>
      <email>tg199@ha.org.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2022</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>Gormin Tan</investigator_full_name>
    <investigator_title>Honorary Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>pericardial effusion, malignancy, pericardiotomy.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion, Malignant</mesh_term>
    <mesh_term>Pericardial Effusion</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/NCT04472468
org study id: C18-004
nct id: NCT04472468
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Pericardial effusion is a common complication in patients with metastatic malignancy. While
      pericardiocentesis provide effective relieve from life-threatening situation such as cardiac
      tamponade, recurrence of pericardial effusion after pericardiocentesis is common. We
      hypothesize that percutaneous balloon pericardiotomy in addition to standard
      pericardiocentesis with prolonged drainage can prevent pericardial effusion recurrence in
      patients with malignant pericardial effusion.
Pericardial effusion is a common complication in patients with metastatic malignancy with an
      incidence as high as 21%. The occurrence of malignant pericardial effusion significantly
      impacts on patient's survival and quality of life. While pericardiocentesis provide effective
      relieve from life-threatening situation such as cardiac tamponade, recurrence of pericardial
      effusion after pericardiocentesis is common and occurs in as high as 31% of patients.
      Retrospective data has shown that prolonged pericardial drainage might reduce the recurrence
      rate but at the cost of increased risk of infection and prolonged hospital stay. Surgical
      pericardiotomy was used in the past but was not shown to reduce recurrence over prolonged
      pericardial drainage and is associated with a higher rate of complications. Surgical
      pericardial window creation via a mini-thoracotomy might be an effective treatment and can be
      considered in patient with pericardial tamponade. The safety and feasibility of Percutaneous
      Balloon pericardiotomy (PBP) has been first described 1993 and has been shown to be an
      alternative treatment for patient with malignant pericardial effusion. However, no data is
      available on the efficacy of PBP in reducing the recurrence of pericardial effusion, in
      comparison with standard pericardiocentesis with prolonged drainage. We aim to perform a
      single centre, randomized, prospective, open label controlled pragmatic trial to compare
      percutaneous balloon pericardiotomy (treatment) to standard pericardiocentesis with prolonged
      drainage (control) in preventing pericardial effusion recurrence in patients with malignant
      pericardial effusion.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: single centre, randomized, prospective, open label controlled pragmatic trial
primary purpose: Treatment
masking: None (Open Label)
measure: Pericardial effusion recurrence
time frame: 3 months
description: Recurrence of pericardial effusion after index procedure, defined as development of moderate or more pericardial effusion (>10mm) on follow-up imaging.
measure: Procedural related complications
time frame: Immediate after intervention
description: Procedural related complications including procedural related death, need for urgent surgical intervention, pleural effusion and pneumothorax
measure: Survival
time frame: 3 months
description: overall survival
measure: Pericardial effusion free survival
time frame: 3 months
description: survival without recurrence of pericardial effusion
measure: cardiac tamponade
time frame: 3 months
description: Occurrence of cardiac tamponade as defined by echocardiographic finding of any of the following: 1. diastolic collapse of the right atrium, 2. Diastolic collapse of the right ventricle, 3. respiratory variation of the mitral E' velocity > 25% or tricuspid E' velocity >40%, 4. dilated IVC >20mm and <50% respiratory reduction.
measure: Quality of life measure (using Functional Assessment of Cancer Therapy - General version (Chinese version)).
time frame: 3 months
description: 27 items self-administered questionnaire examining the impact of a cancer related therapy on 4 domains of life using a 5-points scale.
measure: Pericardial drain indwelling time
time frame: during index procedure
description: Pericardial drain indwelling time at index procedure
measure: Catheter tract tumor seeding
time frame: 3 months
description: Evidence of tumour seeding in catheter tract or extra-pericardial cavity
measure: Ascites/Pleural effusion
time frame: 3 months
description: Occurrence of ascites and pleural effusion by either clinical examination or on radiological investigation.
arm group label: Treatment (pericardiotomy)
arm group type: Experimental
description: Patient in this arm will receive balloon pericardiotomy before insertion of pericardiocentesis.
An 20mm over-the-wire ultra-non-compliant Percutaneous Transluminal Angioplasty Balloon is used to dilate the pericardium.
Success of balloon pericardiotomy is confirmed by full inflation of the balloon which is confirmed on two orthogonal projections.
Standard pericardiocentesis with prolonged drainage is performed afterwards.
Pericardial drain is removed when output is less than 100cc/day
arm group label: Control (standard pericardiocentesis)
arm group type: No Intervention
description: Standard pericardiocentesis procedure is performed using standard pigtail pericardial drain. - Pericardial fluid is then tapped until dry on table.
Pericardial drain is removed when output is less than 100cc/day
intervention type: Device
intervention name: Percutaneous Balloon Pericardiotomy
description: Subxiphoid approach under fluoroscopic guidance is used.
An 20mm over-the-wire ultra-non-compliant Percutaneous Transluminal Angioplasty Balloon is advanced into the pericardial space.
Success of balloon pericardiotomy is confirmed by full inflation of the balloon which is confirmed on two orthogonal projections.
arm group label: Treatment (pericardiotomy)
other name: balloon pericardiotomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GuangMing Tan, MD
phone: 85255699658
email: gtan@cuhk.edu.hk
last name: Daniel Xu
phone: 852 7382 1748
email: xjldaniel@gmail.com
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Gormin Tan
investigator title: Honorary Clinical Assistant Professor
mesh term: Pleural Effusion, Malignant
mesh term: Pericardial Effusion