Pericardial Effusion MalignantPMAPNCT04472468
Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)
A study testing Percutaneous Balloon Pericardiotomy in people with Pericardial Effusion Malignant, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pericardial Effusion Malignant
- What is being tested?
- Percutaneous Balloon Pericardiotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2020to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed active malignancy AND,
- Presence of at least moderate (>10cm) pericardial effusion on CT or Echocardiography
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Percutaneous Balloon Pericardiotomy
- Keywords
- pericardial effusion, malignancy, pericardiotomy.
- Medical subject headings
- Pericardial Effusion, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Balloon PericardiotomyDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (pericardiotomy) | Experimental | * 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 Receives: Device: Percutaneous Balloon Pericardiotomy |
| Control (standard pericardiocentesis) | No intervention | * 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 being measured
The primary outcome is the main question the study is designed to answer.
Pericardial effusion recurrence
Recurrence of pericardial effusion after index procedure, defined as development of moderate or more pericardial effusion (>10mm) on follow-up imaging.
Measured: 3 months
Procedural related complications
Procedural related complications including procedural related death, need for urgent surgical intervention, pleural effusion and pneumothorax
Measured: Immediate after intervention
Secondary outcomes (7)
Survival
overall survival
Measured: 3 months
Pericardial effusion free survival
survival without recurrence of pericardial effusion
Measured: 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.
Measured: 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.
Measured: 3 months
Pericardial drain indwelling time
Pericardial drain indwelling time at index procedure
Measured: during index procedure
Catheter tract tumor seeding
Evidence of tumour seeding in catheter tract or extra-pericardial cavity
Measured: 3 months
Ascites/Pleural effusion
Occurrence of ascites and pleural effusion by either clinical examination or on radiological investigation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start1 Jan 2020
- Primary completion28 Jan 2024
- Study completion30 Sep 2024
Why it stopped: slower than target enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pericardial Effusion MalignantStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multi-center, randomized, prospective, open label controlled pragmatic trial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GuangMing Tan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472468
- Sponsor's protocol ID
- C18-004
- Acronym
- PMAP
- Status last verified
- Nov 2024
- First submitted
- 13 Jul 2020
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP) - a Randomized Study
- ClinicalTrials.gov ID
- NCT04472468
- Acronym / sponsor ID
- PMAP / C18-004
- Conditions
- Pericardial Effusion Malignant
- Keywords
- pericardial effusion, malignancy, pericardiotomy.
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slower than target enrollment.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 28 Jan 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multi-center, randomized, prospective, open label controlled pragmatic trial
| Arm | Type | Receives |
|---|---|---|
| Treatment (pericardiotomy) | Experimental | Device: Percutaneous Balloon 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 |
| Control (standard pericardiocentesis) | No intervention | –* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with confirmed active malignancy AND,
- Presence of at least moderate (>10cm) pericardial effusion on CT or Echocardiography
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Balloon PericardiotomyAlso: 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. | Device | Treatment (pericardiotomy) |
Primary outcome
Pericardial effusion recurrence
Time frame: 3 months
Recurrence of pericardial effusion after index procedure, defined as development of moderate or more pericardial effusion (>10mm) on follow-up imaging.
Procedural related complications
Time frame: Immediate after intervention
Procedural related complications including procedural related death, need for urgent surgical intervention, pleural effusion and pneumothorax
7 secondary outcomes
Survival
Time frame: 3 months
Pericardial effusion free survival
Time frame: 3 months
cardiac tamponade
Time frame: 3 months
Quality of life measure (using Functional Assessment of Cancer Therapy - General version (Chinese version)).
Time frame: 3 months
Pericardial drain indwelling time
Time frame: during index procedure
Catheter tract tumor seeding
Time frame: 3 months
Ascites/Pleural effusion
Time frame: 3 months
Results and safety
The study was stopped early (reason given: slower than target enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Balloon Pericardiotomy in people with Pericardial Effusion Malignant, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slower than target enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pericardial effusion recurrence (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.