search
Back to results

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

Primary Purpose

Pericardial Effusion Malignant

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Percutaneous Balloon Pericardiotomy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pericardial Effusion Malignant focused on measuring pericardial effusion, malignancy, pericardiotomy.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Prince of Wales HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment (pericardiotomy)

Control (standard pericardiocentesis)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 13, 2020
Last Updated
March 7, 2022
Sponsor
Chinese University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT04472468
Brief Title
Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)
Acronym
PMAP
Official Title
Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP) - A Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pericardial Effusion Malignant
Keywords
pericardial effusion, malignancy, pericardiotomy.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single centre, randomized, prospective, open label controlled pragmatic trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (pericardiotomy)
Arm Type
Experimental
Arm Description
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
Arm Title
Control (standard pericardiocentesis)
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Percutaneous Balloon Pericardiotomy
Other Intervention Name(s)
balloon pericardiotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pericardial effusion recurrence
Description
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
Title
Procedural related complications
Description
Procedural related complications including procedural related death, need for urgent surgical intervention, pleural effusion and pneumothorax
Time Frame
Immediate after intervention
Secondary Outcome Measure Information:
Title
Survival
Description
overall survival
Time Frame
3 months
Title
Pericardial effusion free survival
Description
survival without recurrence of pericardial effusion
Time Frame
3 months
Title
cardiac tamponade
Description
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
Title
Quality of life measure (using Functional Assessment of Cancer Therapy - General version (Chinese version)).
Description
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
Title
Pericardial drain indwelling time
Description
Pericardial drain indwelling time at index procedure
Time Frame
during index procedure
Title
Catheter tract tumor seeding
Description
Evidence of tumour seeding in catheter tract or extra-pericardial cavity
Time Frame
3 months
Title
Ascites/Pleural effusion
Description
Occurrence of ascites and pleural effusion by either clinical examination or on radiological investigation.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GuangMing Tan, MD
Phone
85255699658
Email
gtan@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Xu
Phone
852 7382 1748
Email
xjldaniel@gmail.com
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
State/Province
Shatin
ZIP/Postal Code
0000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GuangMing Tan
Phone
85255699658
Email
tg199@ha.org.hk

12. IPD Sharing Statement

Learn more about this trial

Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)

We'll reach out to this number within 24 hrs