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

NCT02477657 | Withdrawn DMC

• 1 other identifier: UPCC 26813
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Malignant Ascites

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  2 years

Interventions

Paracentesis PROCEDURE

Paracentesis

Tunneled Intraperitoneal Drain (IPD) DEVICE

Tunneled Intraperitoneal Drain (IPD)

Peritoneal-Venous shunts (PVS) DEVICE

Peritoneal-Venous shunts (PVS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Paracentesis

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Drainage; Therapeutics; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gregory Nadolski, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 23, 2015
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2023
• Last Updated: January 12, 2022

Record last verified: 2022-01

Locations

US (1)