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

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ClinicalTrials.gov Identifier: NCT02477657
Recruitment Status : Recruiting
First Posted : June 23, 2015
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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
Refractory Malignant Ascites Procedure: Paracentesis Device: Tunneled Intraperitoneal Drain (IPD) Device: Peritoneal-Venous shunts (PVS)

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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology
Study Start Date : April 2015
Estimated Primary Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care




Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with refractory malignant ascites secondary to GU or GI malignancy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477657


Contacts
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Contact: Gregory Nadolski, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Greg Nadolski, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Gregory Nadolski, MD Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02477657     History of Changes
Other Study ID Numbers: UPCC 26813
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: September 2018

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:
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Ascites
Pathologic Processes