Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/7/2018 |
| Start Date: | April 2015 |
| Contact: | Gregory Nadolski, MD |
| Email: | PennCancerTrials@emergingmed.com |
| Phone: | 855-216-0098 |
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.
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.
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
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-6065
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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