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Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP) (PMAP)

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ClinicalTrials.gov Identifier: NCT04472468
Recruitment Status : Recruiting
First Posted : July 15, 2020
Last Update Posted : March 21, 2022
Sponsor:
Information provided by (Responsible Party):
Gormin Tan, Chinese University of Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pericardial Effusion Malignant Device: Percutaneous Balloon Pericardiotomy Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: single centre, randomized, prospective, open label controlled pragmatic trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP) - A Randomized Study
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (pericardiotomy)
  • 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
Device: Percutaneous Balloon Pericardiotomy
  • 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.
Other Name: balloon pericardiotomy

No Intervention: Control (standard pericardiocentesis)
  • 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



Primary Outcome Measures :
  1. Pericardial effusion recurrence [ Time Frame: 3 months ]
    Recurrence of pericardial effusion after index procedure, defined as development of moderate or more pericardial effusion (>10mm) on follow-up imaging.

  2. Procedural related complications [ Time Frame: Immediate after intervention ]
    Procedural related complications including procedural related death, need for urgent surgical intervention, pleural effusion and pneumothorax


Secondary Outcome Measures :
  1. Survival [ Time Frame: 3 months ]
    overall survival

  2. Pericardial effusion free survival [ Time Frame: 3 months ]
    survival without recurrence of pericardial effusion

  3. cardiac tamponade [ Time Frame: 3 months ]
    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.

  4. Quality of life measure (using Functional Assessment of Cancer Therapy - General version (Chinese version)). [ Time Frame: 3 months ]
    27 items self-administered questionnaire examining the impact of a cancer related therapy on 4 domains of life using a 5-points scale.

  5. Pericardial drain indwelling time [ Time Frame: during index procedure ]
    Pericardial drain indwelling time at index procedure

  6. Catheter tract tumor seeding [ Time Frame: 3 months ]
    Evidence of tumour seeding in catheter tract or extra-pericardial cavity

  7. Ascites/Pleural effusion [ Time Frame: 3 months ]
    Occurrence of ascites and pleural effusion by either clinical examination or on radiological investigation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with confirmed active malignancy AND,
  • Presence of at least moderate (>10cm) pericardial effusion on CT or Echocardiography

Exclusion Criteria:

  • Patients unable to give an informed consent,
  • Previous history of open-heart surgery
  • Previous history of pericardial window or pericardial instillation of sclerosing therapy.
  • Scheduled thoracic or cardiac surgery within the next 3 months
  • Patients with contraindications for endovascular procedure such as disseminated intravascular coagulopathy or significant ongoing bleeding tendency, and systemic septicaemia.
  • Patient with small or loculated pericardial effusion that is not accessible by subxiphoid approach.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04472468


Contacts
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Contact: GuangMing Tan, MD 85255699658 gtan@cuhk.edu.hk
Contact: Daniel Xu 852 7382 1748 xjldaniel@gmail.com

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Shatin, Hong Kong, 0000
Contact: GuangMing Tan    85255699658    tg199@ha.org.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
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Responsible Party: Gormin Tan, Honorary Clinical Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04472468    
Other Study ID Numbers: C18-004
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: March 21, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gormin Tan, Chinese University of Hong Kong:
pericardial effusion, malignancy, pericardiotomy.
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pericardial Effusion
Heart Diseases
Cardiovascular Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases