Clinical trial NCT04472468: Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)
Official title: Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP) - a Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pericardial Effusion Malignant
Keywords: pericardial effusion, malignancy, pericardiotomy.
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multi-center, randomized, prospective, open label controlled pragmatic trial
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Pericardial effusion recurrence
timeFrame: 3 months
measure: Procedural related complications
timeFrame: Immediate after intervention
Secondary outcomes:
measure: Survival
timeFrame: 3 months
measure: Pericardial effusion free survival
timeFrame: 3 months
measure: cardiac tamponade
timeFrame: 3 months
measure: Quality of life measure (using Functional Assessment of Cancer Therapy - General version (Chinese version)).
timeFrame: 3 months
measure: Pericardial drain indwelling time
timeFrame: during index procedure
measure: Catheter tract tumor seeding
timeFrame: 3 months
measure: Ascites/Pleural effusion
timeFrame: 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Shatin
Study officials:
References: