Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-25 @ 3:19 PM
Study NCT ID:
NCT04472468
Status:
TERMINATED
Last Update Posted:
2024-11-05
First Post:
2020-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010490', 'term': 'Pericardial Effusion'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multi-center, randomized, prospective, open label controlled pragmatic trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'whyStopped': 'slower than target enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2020-07-13', 'studyFirstSubmitQcDate': '2020-07-14', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pericardial effusion recurrence', 'timeFrame': '3 months', 'description': 'Recurrence of pericardial effusion after index procedure, defined as development of moderate or more pericardial effusion (\\>10mm) on follow-up imaging.'}, {'measure': 'Procedural related complications', 'timeFrame': 'Immediate after intervention', 'description': 'Procedural related complications including procedural related death, need for urgent surgical intervention, pleural effusion and pneumothorax'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': '3 months', 'description': 'overall survival'}, {'measure': 'Pericardial effusion free survival', 'timeFrame': '3 months', 'description': 'survival without recurrence of pericardial effusion'}, {'measure': 'cardiac tamponade', 'timeFrame': '3 months', '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."}, {'measure': 'Quality of life measure (using Functional Assessment of Cancer Therapy - General version (Chinese version)).', 'timeFrame': '3 months', 'description': '27 items self-administered questionnaire examining the impact of a cancer related therapy on 4 domains of life using a 5-points scale.'}, {'measure': 'Pericardial drain indwelling time', 'timeFrame': 'during index procedure', 'description': 'Pericardial drain indwelling time at index procedure'}, {'measure': 'Catheter tract tumor seeding', 'timeFrame': '3 months', 'description': 'Evidence of tumour seeding in catheter tract or extra-pericardial cavity'}, {'measure': 'Ascites/Pleural effusion', 'timeFrame': '3 months', 'description': 'Occurrence of ascites and pleural effusion by either clinical examination or on radiological investigation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pericardial effusion, malignancy, pericardiotomy.'], 'conditions': ['Pericardial Effusion Malignant']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with confirmed active malignancy AND,\n* Presence of at least moderate (\\>10cm) pericardial effusion on CT or Echocardiography\n\nExclusion Criteria:\n\n* Patients unable to give an informed consent,\n* Previous history of open-heart surgery\n* Previous history of pericardial window or pericardial instillation of sclerosing therapy.\n* Scheduled thoracic or cardiac surgery within the next 3 months\n* Patients with contraindications for endovascular procedure such as disseminated intravascular coagulopathy or significant ongoing bleeding tendency, and systemic septicaemia.\n* Patient with small or loculated pericardial effusion that is not accessible by subxiphoid approach.'}, 'identificationModule': {'nctId': 'NCT04472468', 'acronym': 'PMAP', 'briefTitle': 'Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP) - a Randomized Study', 'orgStudyIdInfo': {'id': 'C18-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (pericardiotomy)', 'description': '* Patient in this arm will receive balloon pericardiotomy before insertion of pericardiocentesis.\n* An 20mm over-the-wire ultra-non-compliant Percutaneous Transluminal Angioplasty Balloon is used to dilate the pericardium.\n* Success of balloon pericardiotomy is confirmed by full inflation of the balloon which is confirmed on two orthogonal projections.\n* Standard pericardiocentesis with prolonged drainage is performed afterwards.\n* 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.\n* Pericardial drain is removed when output is less than 100cc/day'}], 'interventions': [{'name': 'Percutaneous Balloon Pericardiotomy', 'type': 'DEVICE', 'otherNames': ['balloon pericardiotomy'], 'description': '* Subxiphoid approach under fluoroscopic guidance is used.\n* An 20mm over-the-wire ultra-non-compliant Percutaneous Transluminal Angioplasty Balloon is advanced into the pericardial space.\n* Success of balloon pericardiotomy is confirmed by full inflation of the balloon which is confirmed on two orthogonal projections.', 'armGroupLabels': ['Treatment (pericardiotomy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Hong Kong', 'state': 'Shatin', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Honorary Clinical Assistant Professor', 'investigatorFullName': 'GuangMing Tan', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}