Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)

Pericardial Effusion Malignant Clinical Trial

— PMAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04472468
• Other study ID #: C18-004
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2022
• Source: Chinese University of Hong Kong
• Contact: GuangMing Tan, MD
• Phone: 85255699658
• Email: gtan[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pericardial Effusion
• Pericardial Effusion Malignant
• Pleural Effusion, Malignant

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Procedural related complications	Procedural related complications including procedural related death, need for urgent surgical intervention, pleural effusion and pneumothorax	Immediate after intervention
Secondary	Survival	overall survival	3 months
Secondary	Pericardial effusion free survival	survival without recurrence of pericardial effusion	3 months
Secondary	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
Secondary	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
Secondary	Pericardial drain indwelling time	Pericardial drain indwelling time at index procedure	during index procedure
Secondary	Catheter tract tumor seeding	Evidence of tumour seeding in catheter tract or extra-pericardial cavity	3 months
Secondary	Ascites/Pleural effusion	Occurrence of ascites and pleural effusion by either clinical examination or on radiological investigation.	3 months