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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02477657

Enrollment

Registered

2015-06-23

Start date

2021-07-31

Completion date

2023-07-31

Last updated

2022-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Malignant Ascites

Keywords

Adult patients with refractory malignant ascites secondary to GU or GI malignancy.

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.

Interventions

PROCEDUREParacentesis

Paracentesis

DEVICETunneled Intraperitoneal Drain (IPD)

Tunneled Intraperitoneal Drain (IPD)

DEVICEPeritoneal-Venous shunts (PVS)

Peritoneal-Venous shunts (PVS)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of Adverse Events	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026