Clinical trial · Interventional
Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)
Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP) - a Randomized Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slower than target enrollment.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pericardial Effusion Malignant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Percutaneous Balloon Pericardiotomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment (pericardiotomy)
- 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
- interventionNames
- Device: Percutaneous Balloon Pericardiotomy
- type
- NO_INTERVENTION
- label
- Control (standard pericardiocentesis)
- 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
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available