TerminatedNCT01077063Updated Oct 29, 2015Results posted

An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites

An interventional study of paracentesis and Pleurx catheter in Malignant Ascites, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2015-10-29.

Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Not applicable, Interventional, and Treatment

Why this study was terminated

Study was closed by PI because of low enrollment.

Phase: Not applicable
Study type: Interventional
Enrollment: 7
Allocation: Randomized
Ages: 18 Years to 100 Years
Sex: All

Study 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 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 studied

Malignant Ascites

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Ascites 252

Keywords

Pleurx catheter
malignant ascites

In context

Ascites

252 studies on the registry are indexed under Ascites; 52 are open to participants now.

This study's enrollment of 7 is below the median of 55 across 177 interventional studies indexed under Ascites.

Browse Ascites studies →

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 100 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

(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
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

Exclusion criteria

Exclusion criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 7 participants (actual)

Study arms

Active comparator
paracentesis
cutting and draining procedure for malignant ascites
Procedure: paracentesis
Active comparator
Pleurx catheter
a catheter drainage system the subject uses himself/herself.
Device: Pleurx catheter

Interventions

Procedureparacentesis
surgical drainage of malignant ascites
DevicePleurx catheter
take home catheter drainage system that the subject uses himself/herself as needed.

What researchers measure

Primary outcomes

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.
Time frame: 3 years

Results

Posted Sep 22, 2014

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.

Participant flow

Participant flow — Overall Study
Milestone	Pleurx Catheter	Paracentesis
Started	4	3
Completed	0	0
Not completed	4	3
Withdrew: Adverse event	3	0
Withdrew: Death	1	1
Withdrew: Withdrawal by subject	0	2

Outcome measures

PrimarySafety 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.

Time frame:: 3 years
Reported as:: Number · events

Safety of Pleurx Catheter or Paracentesis
events	Paracentesis	Pleurx Catheter
Related peritonitis	0	0
Related death	0	0
Related perforation	0	0
Unnacceptable other (related)	0	1

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Paracentesis	—	1/3 (33.3%)	3/3 (100%)
Pleurx Catheter	—	3/4 (75%)	4/4 (100%)

Most frequent serious events

Showing 10 of 11

Most frequent serious events
Event	Paracentesis	Pleurx Catheter
sepsisInfections and infestations	1/3	0/4
renal failureRenal and urinary disorders	1/3	0/4
hypotensionCardiac disorders	1/3	0/4
peritonitisInfections and infestations	1/3	0/4
abdominal painGastrointestinal disorders	1/3	0/4
nauseaGastrointestinal disorders	0/3	1/4
vomitingGastrointestinal disorders	0/3	1/4
abdominal crampsGastrointestinal disorders	0/3	1/4
infection (non septic)Infections and infestations	0/3	1/4
bowel obstructionGastrointestinal disorders	0/3	1/4

Most frequent other events

Showing 10 of 41

Most frequent other events
Event	Paracentesis	Pleurx Catheter
↑ alkaline phosphataseInvestigations	1/3	3/4
↑ ALTInvestigations	2/3	2/4
↓ calciumMetabolism and nutrition disorders	2/3	1/4
↓ lymphocytesBlood and lymphatic system disorders	2/3	2/4
↓ magnesiumMetabolism and nutrition disorders	2/3	0/4
↓ sodiumMetabolism and nutrition disorders	2/3	2/4
bilateral lower extremity pitting edemaBlood and lymphatic system disorders	2/3	0/4
decreased appetiteGastrointestinal disorders	2/3	0/4
fatigueGeneral disorders	2/3	1/4
↑ ASTInvestigations	1/3	2/4

Baseline characteristics

subjects with malignant ascites

Age, Continuous
Age, Continuous(years)	Paracentesis	Pleurx Catheter	Total
Mean	53.67 (42 to 62)	55 (45 to 70)	54.42 (42 to 70)

Age, Categorical
Age, Categorical(Participants)	Paracentesis	Pleurx Catheter	Total
<=18 years	0	0	0
Between 18 and 65 years	3	3	6
>=65 years	0	1	1

Sex: Female, Male
Sex: Female, Male(Participants)	Paracentesis	Pleurx Catheter	Total
Female	1	1	2
Male	2	3	5

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Paracentesis	Pleurx Catheter	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	1	0	1
White	2	4	6
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Paracentesis	Pleurx Catheter	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	3	4	7
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Paracentesis	Pleurx Catheter	Total
United States	3	4	7

Study locations

1 site

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21205-2009, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01077063
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Responsible party: Sponsor
First posted: Feb 26, 2010
Start date: Feb 2010
Primary completion: Aug 2013
Completion: Aug 2013
Results posted: Sep 22, 2014
Last update: Oct 29, 2015

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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