Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)

The Chinese University of Hong Kong

Status: Terminated

Conditions: Pericardial Effusion Malignant

Treatments: Device: Percutaneous Balloon Pericardiotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04472468

C18-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Treatment (pericardiotomy)

Experimental group

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

Treatment:

Device: Percutaneous Balloon Pericardiotomy

Control (standard pericardiocentesis)

No Intervention group

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