Trial Outcomes & Findings for An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites (NCT NCT01077063)
NCT ID: NCT01077063
Last Updated: 2015-10-29
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
3 years
Results posted on
2015-10-29
Participant Flow
Participant milestones
| Measure |
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.
|
Paracentesis
cutting and draining procedure for malignant ascites
paracentesis: surgical drainage of malignant ascites
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
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.
|
Paracentesis
cutting and draining procedure for malignant ascites
paracentesis: surgical drainage of malignant ascites
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites
Baseline characteristics by cohort
| Measure |
Paracentesis
n=3 Participants
cutting and draining procedure for malignant ascites
paracentesis: surgical drainage of malignant ascites
|
Pleurx Catheter
n=4 Participants
a catheter drainage system the subject uses himself/herself.
Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.67 years
n=5 Participants
|
55 years
n=7 Participants
|
54.42 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPrimary 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.
Outcome measures
| Measure |
Paracentesis
n=3 Participants
cutting and draining procedure for malignant ascites
paracentesis: surgical drainage of malignant ascites
|
Pleurx Catheter
n=4 Participants
a catheter drainage system the subject uses himself/herself.
Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed.
|
|---|---|---|
|
Safety of Pleurx Catheter or Paracentesis
Related peritonitis
|
0 events
|
0 events
|
|
Safety of Pleurx Catheter or Paracentesis
Related death
|
0 events
|
0 events
|
|
Safety of Pleurx Catheter or Paracentesis
Related perforation
|
0 events
|
0 events
|
|
Safety of Pleurx Catheter or Paracentesis
Unnacceptable other (related)
|
0 events
|
1 events
|
Adverse Events
Paracentesis
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Pleurx Catheter
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paracentesis
n=3 participants at risk
cutting and draining procedure for malignant ascites
paracentesis: surgical drainage of malignant ascites
|
Pleurx Catheter
n=4 participants at risk
a catheter drainage system the subject uses himself/herself.
Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed.
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
abdominal cramps
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
infection (non septic)
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
bowel obstruction
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
General disorders
fatigue
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
sepsis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Renal and urinary disorders
renal failure
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Cardiac disorders
hypotension
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Infections and infestations
peritonitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
abdominal pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
Other adverse events
| Measure |
Paracentesis
n=3 participants at risk
cutting and draining procedure for malignant ascites
paracentesis: surgical drainage of malignant ascites
|
Pleurx Catheter
n=4 participants at risk
a catheter drainage system the subject uses himself/herself.
Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed.
|
|---|---|---|
|
Investigations
↑ alkaline phosphatase
|
33.3%
1/3 • Number of events 2
|
75.0%
3/4 • Number of events 4
|
|
Investigations
↑ ALT
|
66.7%
2/3 • Number of events 3
|
50.0%
2/4 • Number of events 4
|
|
Investigations
↑ AST
|
33.3%
1/3 • Number of events 2
|
50.0%
2/4 • Number of events 3
|
|
Investigations
↑ CK serum
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Investigations
↑ creatinine
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
↑ glucose
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
↑ potassium
|
33.3%
1/3 • Number of events 4
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
↑ magnesium
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Investigations
↑ total bilirubin
|
33.3%
1/3 • Number of events 2
|
50.0%
2/4 • Number of events 2
|
|
Investigations
↑ PT
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Investigations
↑ PTT
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
|
Metabolism and nutrition disorders
↑ uric acid
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
↓ albumin
|
33.3%
1/3 • Number of events 3
|
50.0%
2/4 • Number of events 4
|
|
Metabolism and nutrition disorders
↓ calcium
|
66.7%
2/3 • Number of events 3
|
25.0%
1/4 • Number of events 2
|
|
Metabolism and nutrition disorders
↓ glucose
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
↓ hemoglobin
|
33.3%
1/3 • Number of events 1
|
50.0%
2/4 • Number of events 5
|
|
Blood and lymphatic system disorders
↓ lymphocytes
|
66.7%
2/3 • Number of events 6
|
50.0%
2/4 • Number of events 3
|
|
Metabolism and nutrition disorders
↓ magnesium
|
66.7%
2/3 • Number of events 2
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
↓ sodium
|
66.7%
2/3 • Number of events 3
|
50.0%
2/4 • Number of events 5
|
|
Blood and lymphatic system disorders
↓ platelets
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
↓ potassium
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
↓ total protein
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
↓ white blood cells
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
abdominal pain
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 5
|
|
Gastrointestinal disorders
anorexia
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
bilateral lower extremity pitting edema
|
66.7%
2/3 • Number of events 3
|
0.00%
0/4
|
|
Gastrointestinal disorders
bloating
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Renal and urinary disorders
dark urine
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
daytime somnolence
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
decreased appetite
|
66.7%
2/3 • Number of events 2
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
dehydration
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
early satiety
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
General disorders
fatigue
|
66.7%
2/3 • Number of events 4
|
25.0%
1/4 • Number of events 2
|
|
General disorders
icterus
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
loss of muscle mass
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
mucositis
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 2
|
|
Gastrointestinal disorders
nausea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Nervous system disorders
numbness right foot
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
rectal bleeding
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
reddened rash on abdomen
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
Additional Information
Daniel Laheru, MD
Sidney Kimmel Comprehensive Cancer Center at JHMI
Phone: 410-955-8974
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place