Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology

Withdrawn

• Conditions: Refractory Malignant Ascites

• Registration Number: NCT02477657
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-16
• Study First Submitted QC: 2015-06-18
• Study First Posted: 2015-06-23
• Study Start: 2021-07
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-12
• Primary Completion: 2022-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	2 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States