Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP) (PMAP)

Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP) - A Randomized Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pericardial Effusion Malignant
• Intervention / Treatment: Device: Percutaneous Balloon Pericardiotomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GuangMing Tan, MD; Phone Number: 85255699658; Email: gtan@cuhk.edu.hk
• Study Contact Backup: Name: Daniel Xu; Phone Number: 852 7382 1748; Email: xjldaniel@gmail.com

Study Locations

• Hong Kong
  • Shatin
    • Hong Kong, Shatin, Hong Kong, 0000
      • Recruiting
      • Prince Of Wales Hospital
      • Contact: GuangMing Tan; Phone Number: 85255699658; Email: tg199@ha.org.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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.; Other Names: balloon pericardiotomy
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pericardial effusion recurrence	Recurrence of pericardial effusion after index procedure, defined as development of moderate or more pericardial effusion (>10mm) on follow-up imaging.	3 months
Procedural related complications	Procedural related complications including procedural related death, need for urgent surgical intervention, pleural effusion and pneumothorax	Immediate after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	overall survival	3 months
Pericardial effusion free survival	survival without recurrence of pericardial effusion	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.	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.	3 months
Pericardial drain indwelling time	Pericardial drain indwelling time at index procedure	during index procedure
Catheter tract tumor seeding	Evidence of tumour seeding in catheter tract or extra-pericardial cavity	3 months
Ascites/Pleural effusion	Occurrence of ascites and pleural effusion by either clinical examination or on radiological investigation.	3 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: pericardial effusion, malignancy, pericardiotomy.
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion; Pleural Effusion, Malignant; Pericardial Effusion
• Other Study ID Numbers: C18-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No