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

Refractory Malignant Ascites Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02477657
• Other study ID #: UPCC 26813
• Status: Withdrawn
• Start date: July 2021
• Est. completion date: July 2023

Study information

• Verified date: January 2022
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2023
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Refractory Malignant Ascites

Intervention

Procedure:
• Paracentesis
Paracentesis

Device:
• Tunneled Intraperitoneal Drain (IPD)
Tunneled Intraperitoneal Drain (IPD)
• Peritoneal-Venous shunts (PVS)
Peritoneal-Venous shunts (PVS)

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		2 years