Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-04-22 @ 10:10 PM
Study NCT ID:
NCT02477657
Status:
WITHDRAWN
Last Update Posted:
2022-01-12
First Post:
2015-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019152', 'term': 'Paracentesis'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Industry funding not received. No subjects enrolled.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-11', 'studyFirstSubmitDate': '2015-06-16', 'studyFirstSubmitQcDate': '2015-06-18', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adult patients with refractory malignant ascites secondary to GU or GI malignancy.'], 'conditions': ['Refractory Malignant Ascites']}, 'descriptionModule': {'briefSummary': 'Malignant ascites leads to significant morbidity in patients with terminal cancer. Paracentesis can provide relief, but repeat hospital visits, pain, and short duration of relief after paracentesis are detrimental to quality of life(QOL). Two devices are available as alternatives to paracentesis. The impact of either device on QOL has not fully been explored. A pilot nonrandomized trial measuring palliative care QOL and ascites symptom relief using validated survey instruments is proposed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with refractory malignant ascites secondary to GU or GI malignancy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refractory malignant ascites defined as ascites requiring more than one paracentesis to control patient symptoms despite medical therapy with diuretics and a. peritoneal fluid with cytology positive for malignant cells OR\n* Known malignancy with imaging findings of peritoneal carcinomatosis .\n* Eastern Cooperative Oncology Group (ECOG) performance score 3\n* Age greater than or equal to 18\n* Capable of giving informed consent\n\nExclusion Criteria:\n\n* Life expectancy less than one month\n* Coagulopathy defined as international normalized ration (INR) \\>2 which cannot be corrected with fresh frozen plasma\n* Platelet count \\<50,000/microliter, which cannot be corrected with platelet transfusion\n* Active skin infections at sites where PVS would be inserted\n* Presence of infectious peritonitis or bacteremia\n* Neutropenia\n* American Heart Association Class D congestive heart failure (ie New York Heart Association Class IV)\n* Stage 5 CKD (ie GFR \\< 15 mL/min)\n* Severe hypoalbuminemia defined as \\< 2.2 g/dL\n* Loculated or hemorrhagic ascites\n* History of bleeding gastroesophageal varices\n* Inability to provide informed consent\n* Unable to participate in neuropsychological tests / questionnaires\n* Pregnant or nursing women\n* Anasarca'}, 'identificationModule': {'nctId': 'NCT02477657', 'briefTitle': 'Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology', 'orgStudyIdInfo': {'id': 'UPCC 26813'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Paracentesis', 'type': 'PROCEDURE', 'description': 'Paracentesis'}, {'name': 'Tunneled Intraperitoneal Drain (IPD)', 'type': 'DEVICE', 'description': 'Tunneled Intraperitoneal Drain (IPD)'}, {'name': 'Peritoneal-Venous shunts (PVS)', 'type': 'DEVICE', 'description': 'Peritoneal-Venous shunts (PVS)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Gregory Nadolski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}