Malignant Ascites
Conditions
Keywords
Pleurx catheter, malignant ascites
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.
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
Interventions
PROCEDUREparacentesis
surgical drainage of malignant ascites
DEVICEPleurx catheter
take home catheter drainage system that the subject uses himself/herself as needed.
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
(Patients can receive chemotherapy at the discretion of treating oncologist) 1. Patients with recurrent malignant ascites 2. Patients with refractory malignant ascites 3. Proven malignancy 4. Age \>= 18 years old 5. Eastern Cooperative Oncology Group (ECOG) performance scale =\< 2 6. Ability to understand and willingness to sign a written informed consent Definitions: Malignant ascites: One of the following criteria 1. Positive ascitic fluid cytology 2. Histology proven malignancy with imaging studies with evidence of liver metastasis and ascites 3. Malignant Budd Chiari Syndrome with associated ascites 4. Hepatocellular carcinoma and ascites 5. Chylous ascites due to lymphoma 6. Peritoneal carcinomatosis and concurrent ascites 7. Proven abdominal malignancy with concurrent ascites Refractory / Recurrent ascites: One of the following criteria 1. Symptomatic ascites that recurred after one paracentesis in a patient with known malignant ascites. 2. Symptomatic ascites that did not respond clinically to at least two weeks of diuretics. Use of diuretics at the discretion of the treating physician. 3. 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). 4. Removal of at least 5 L in the preceding two months for symptoms relief
Exclusion criteria
1. Life expectancy less than one month 2. Coagulopathy (international normalized ratio \[INR\] \> 2 that does not correct with fresh frozen plasma) 3. Hepatorenal syndrome 4. Active skin infections at abdomen before procedures 5. Inability to provide inform consent 6. Platelet counts \< 50,000/mcL 7. 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 8. Absolute neutrophil count \<1000 / cu mm 9. Pregnant women 10. Multiloculated ascites
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Pleurx Catheter or Paracentesis | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paracentesis cutting and draining procedure for malignant ascites
paracentesis: surgical drainage of malignant ascites | 3 |
| Pleurx Catheter a catheter drainage system the subject uses himself/herself.
Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed. | 4 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Death | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Paracentesis | Pleurx Catheter | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Continuous | 53.67 years | 55 years | 54.42 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 6 Participants |
| Region of Enrollment United States | 3 participants | 4 participants | 7 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 4 / 4 |
| serious Total, serious adverse events | 1 / 3 | 3 / 4 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paracentesis | Safety of Pleurx Catheter or Paracentesis | Related peritonitis | 0 events |
| Paracentesis | Safety of Pleurx Catheter or Paracentesis | Related perforation | 0 events |
| Paracentesis | Safety of Pleurx Catheter or Paracentesis | Related death | 0 events |
| Paracentesis | Safety of Pleurx Catheter or Paracentesis | Unnacceptable other (related) | 0 events |
| Pleurx Catheter | Safety of Pleurx Catheter or Paracentesis | Related death | 0 events |
| Pleurx Catheter | Safety of Pleurx Catheter or Paracentesis | Related peritonitis | 0 events |
| Pleurx Catheter | Safety of Pleurx Catheter or Paracentesis | Unnacceptable other (related) | 1 events |
| Pleurx Catheter | Safety of Pleurx Catheter or Paracentesis | Related perforation | 0 events |