Study Stopped
Study was closed by PI because of low enrollment.
An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites
2 other identifiers
interventional
7
1 country
1
Brief Summary
The purpose of this study is to assess in a controlled prospective setting, the safety of the use of Pleurx catheters and standard therapeutic paracentesis in patients with malignant ascites.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 25, 2010
CompletedFirst Posted
Study publicly available on registry
February 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
September 22, 2014
CompletedOctober 29, 2015
October 1, 2015
3.5 years
February 25, 2010
September 15, 2014
October 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of Pleurx Catheter or Paracentesis
Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis Safety of the pleurx catheter procedure or paracentesis. Safety will be assessed by the degree of unacceptable toxicities, defined as life threatening complications related to the procedure. These include peritonitis, perforation, or death related to the procedure.
3 years
Study Arms (2)
paracentesis
ACTIVE COMPARATORcutting and draining procedure for malignant ascites
Pleurx catheter
ACTIVE COMPARATORa catheter drainage system the subject uses himself/herself.
Interventions
take home catheter drainage system that the subject uses himself/herself as needed.
Eligibility Criteria
You may qualify if:
- (Patients can receive chemotherapy at the discretion of treating oncologist)
- Patients with recurrent malignant ascites
- Patients with refractory malignant ascites
- Proven malignancy
- Age \>= 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance scale =\< 2
- Ability to understand and willingness to sign a written informed consent
- Definitions:
- Malignant ascites: One of the following criteria
- Positive ascitic fluid cytology
- Histology proven malignancy with imaging studies with evidence of liver metastasis and ascites
- Malignant Budd Chiari Syndrome with associated ascites
- Hepatocellular carcinoma and ascites
- Chylous ascites due to lymphoma
- Peritoneal carcinomatosis and concurrent ascites
- +6 more criteria
You may not qualify if:
- Life expectancy less than one month
- Coagulopathy (international normalized ratio \[INR\] \> 2 that does not correct with fresh frozen plasma)
- Hepatorenal syndrome
- Active skin infections at abdomen before procedures
- Inability to provide inform consent
- Platelet counts \< 50,000/mcL
- Uncontrolled illness including, but not limited to, ongoing or active infection requiring intravenous (IV) antibiotics, that the physician feels would increase the risk of infection with the procedures or white blood cell (WBC) count \> 20,000/mcL
- Absolute neutrophil count \<1000 / cu mm
- Pregnant women
- Multiloculated ascites
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21205-2009, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was closed by investigator due to low enrollment. Subject JH006 S-B did have abdominal pain, post Pleurx placement, so it was removed and she was taken out of the study.
Results Point of Contact
- Title
- Daniel Laheru, MD
- Organization
- Sidney Kimmel Comprehensive Cancer Center at JHMI
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2010
First Posted
February 26, 2010
Study Start
February 1, 2010
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
October 29, 2015
Results First Posted
September 22, 2014
Record last verified: 2015-10