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

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02477657
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Refractory Malignant Ascites	Procedure: Paracentesis; Device: Tunneled Intraperitoneal Drain (IPD); Device: Peritoneal-Venous shunts (PVS)

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology
• Anticipated Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 1, 2023

Outcome Measures

Primary Outcome Measures

1. Number of Adverse Events [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02477657
• Other Study ID Numbers: UPCC 26813
• First Posted: Jun 23, 2015
• Last Update Posted: Jan 12, 2022
• Last Verified: Jan 1, 2022

• Keywords provided by Abramson Cancer Center of the University of Pennsylvania: Adult patients with refractory malignant ascites secondary to GU or GI malignancy.
• Additional relevant MeSH terms: Ascites

Study Results

No Results Posted as of Jan 12, 2022