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

January 11, 2022 updated by: Abramson Cancer Center of the University of Pennsylvania
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Adverse Events
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Gregory Nadolski, MD, Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

June 16, 2015

First Submitted That Met QC Criteria

June 18, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Actual)

January 12, 2022

Last Update Submitted That Met QC Criteria

January 11, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 26813

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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