Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP) (PMAP)
Pericardial Effusion Malignant
About this trial
This is an interventional treatment trial for Pericardial Effusion Malignant focused on measuring pericardial effusion, malignancy, pericardiotomy.
Eligibility 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.
Sites / Locations
- Prince of Wales HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Treatment (pericardiotomy)
Control (standard pericardiocentesis)
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
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