Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology (NCT02477657) | Clinical Trial Compass
WithdrawnNot Applicable
Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology
Stopped: Industry funding not received. No subjects enrolled.
United States0Started 2021-07
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Known malignancy with imaging findings of peritoneal carcinomatosis .
* Eastern Cooperative Oncology Group (ECOG) performance score 3
* Age greater than or equal to 18
* Capable of giving informed consent
Exclusion Criteria:
* Life expectancy less than one month
* Coagulopathy defined as international normalized ration (INR) \>2 which cannot be corrected with fresh frozen plasma
* Platelet count \<50,000/microliter, which cannot be corrected with platelet transfusion
* Active skin infections at sites where PVS would be inserted
* Presence of infectious peritonitis or bacteremia
* Neutropenia
* American Heart Association Class D congestive heart failure (ie New York Heart Association Class IV)
* Stage 5 CKD (ie GFR \< 15 mL/min)
* Severe hypoalbuminemia defined as \< 2.2 g/dL
* Loculated or hemorrhagic ascites
* History of bleeding gastroesophageal varices
* Inability to provide informed consent
* Unable to participate in neuropsychological tests / questionnaires
* Pregnant or nursing women
* Anasarca
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.