Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)

Chinese University of Hong Kong50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pericardial Effusion Malignant

Interventions

Percutaneous Balloon PericardiotomyDEVICE

* 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Prince of Wales Hospital

Hong Kong, Shatin, Hong Kong

Outcomes

Primary Outcomes

Pericardial effusion recurrence

Recurrence of pericardial effusion after index procedure, defined as development of moderate or more pericardial effusion (\>10mm) on follow-up imaging.

Time frame: 3 months

Procedural related complications

Procedural related complications including procedural related death, need for urgent surgical intervention, pleural effusion and pneumothorax

Time frame: Immediate after intervention

Secondary Outcomes

Survival

overall survival

Time frame: 3 months

Pericardial effusion free survival

survival without recurrence of pericardial effusion

Time frame: 3 months

cardiac tamponade

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.

Time frame: 3 months

Quality of life measure (using Functional Assessment of Cancer Therapy - General version (Chinese version)).

27 items self-administered questionnaire examining the impact of a cancer related therapy on 4 domains of life using a 5-points scale.

Time frame: 3 months

Pericardial drain indwelling time

Pericardial drain indwelling time at index procedure

Time frame: during index procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.