Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)

NCT ID: NCT04472468

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-09-30

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.

Conditions

Pericardial Effusion Malignant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (pericardiotomy)

• 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

Group Type: EXPERIMENTAL

Percutaneous Balloon Pericardiotomy

Intervention Type: DEVICE

• 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.

Control (standard pericardiocentesis)

• 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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Percutaneous Balloon Pericardiotomy

• 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.

Intervention Type: DEVICE

Other Intervention Names

balloon 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

GuangMing Tan

Honorary Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prince of Wales Hospital

Hong Kong, Shatin, Hong Kong

Countries

Hong Kong

Other Identifiers

C18-004

Identifier Type: -

Identifier Source: org_study_id