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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    150
  • sponsor
    Chinese University of Hong Kong
Updated on 13 April 2022

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.

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.

Details
Condition Pericardial Effusion Malignant
Treatment Percutaneous Balloon Pericardiotomy
Clinical Study IdentifierNCT04472468
SponsorChinese University of Hong Kong
Last Modified on13 April 2022

Eligibility

Yes No Not Sure

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
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