Malignant AscitesNCT01077063
An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites
A study testing paracentesis and Pleurx catheter in people with Malignant Ascites, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Malignant Ascites
- What is being tested?
- paracentesis and Pleurx catheter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
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- 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
- Proven abdominal malignancy with concurrent ascites
- Refractory / Recurrent ascites: One of the following criteria
- Symptomatic ascites that recurred after one paracentesis in a patient with known malignant ascites.
- Symptomatic ascites that did not respond clinically to at least two weeks of diuretics. Use of diuretics at the discretion of the treating physician.
- Intolerance or relative contraindications to diuretics: (serum sodium (Na) concentration of <125 mmol per liter or serum creatinine >1.5 mg/dl, hyperkalemia (potassium >5.2 mEq/L or azotemia Bun/Creatinine ratio > 20).
- Removal of at least 5 L in the preceding two months for symptoms relief
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21205-2009
About this study
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.
Read the detailed description
Study Design: Single institution, open-label, randomized study
Study Device: Pleurx Catheter
Treatment Plan: Cohort A: 15 patients treated with standard therapy (therapeutic paracentesis +/- diuretics)
Cohort B: 15 patients treated with peritoneal Pleurx catheter
Duration of Participation: Patients will be followed for one year, or until death, whichever comes first.
Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis
Secondary outcomes: Overall complications, quality of life, overall survival, and symptom control
- Conditions
- Malignant Ascites
- Being tested
- paracentesis, Pleurx catheter
- Keywords
- Pleurx catheter, malignant ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracentesisProcedure or surgery
surgical drainage of malignant ascites
Pleurx catheterDevice
take home catheter drainage system that the subject uses himself/herself as needed.
| Study group | Role | What they receive |
|---|---|---|
| paracentesis | Active comparator | cutting and draining procedure for malignant ascites Receives: Procedure: paracentesis |
| Pleurx catheter | Active comparator | a catheter drainage system the subject uses himself/herself. Receives: Device: Pleurx catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: Study was closed by PI because of low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant AscitesStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077063
- Sponsor's protocol ID
- J0940
- Other IDs
- Carefusion
- Status last verified
- Oct 2015
- First submitted
- 25 Feb 2010
- Last updated
- 29 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites
- ClinicalTrials.gov ID
- NCT01077063
- Acronym / sponsor ID
- J0940
- Conditions
- Malignant Ascites
- Keywords
- Pleurx catheter, malignant ascites
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was closed by PI because of low enrollment.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Posted 22 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design: Single institution, open-label, randomized study
Study Device: Pleurx Catheter
Treatment Plan: Cohort A: 15 patients treated with standard therapy (therapeutic paracentesis +/- diuretics)
Cohort B: 15 patients treated with peritoneal Pleurx catheter
Duration of Participation: Patients will be followed for one year, or until death, whichever comes first.
Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis
Secondary outcomes: Overall complications, quality of life, overall survival, and symptom control
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paracentesis | Active comparator | Procedure: paracentesiscutting and draining procedure for malignant ascites |
| Pleurx catheter | Active comparator | Device: Pleurx cathetera catheter drainage system the subject uses himself/herself. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- (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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paracentesissurgical drainage of malignant ascites | Procedure or surgery | paracentesis |
| Pleurx cathetertake home catheter drainage system that the subject uses himself/herself as needed. | Device | Pleurx catheter |
Primary outcome
Safety of Pleurx Catheter or Paracentesis
Time frame: 3 years
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paracentesis and Pleurx catheter in people with Malignant Ascites, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Pleurx Catheter or Paracentesis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015.