Prospective Evaluation of PleurX Drain for Treatment of Cirrhotic Refractory Ascites
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alberta
- Enrollment
- 12
- Primary Endpoint
- Ascites Symptom Inventory (ASI-7)
Study Overview
Brief Summary
Refractory ascites (fluid build up in the abdomen that can not bet managed by medications) occurs in at least 10% of patients with end stage liver disease (cirrhosis). Two major options for management include large volume paracentesis (LVP)-drainage with a needle through the abdominal wall) and placement of a transjugular intrahepatic portosystemic shunt (TIPS)-re-directs blood flow across the cirrhotic liver), Not all patients are candidates for TIPS or transplant, are left with LVP as the only long-term treatment option. Patients listed for transplant require LVP while they wait for transplant.
LVP can cause pain, bleeding, leakage from the drain site and frequent hospital visits which result in health care cost as well as patient and caregiver fatigue. In between the drains, living with ascites can negatively affect quality of life because of discomfort and limitations. Patients with ascites are more malnourished than those without.
Specialized drains tunnelled under the skin, are used in patents with ascites due to cancer (malignant). There are not many studies evaluating these drains in patients with cirrhosis, One of the reasons for the lack of studies is the potential for infection. As opposed to malignant ascites, cirrhotic ascites generally has a low protein content, a risk factor for development of spontaneous bacterial peritonitis (SBP). From available studies, infection rates in cirrhotic patients with tunnelled drains who are not on antibiotics are estimated at 10% (4/40). Infection rates on antibiotic prophylaxis would be expected to be lower.
This pilot study includes the evaluation of indwelling tunnelled PleurX catheters as an alternative option. The hypothesis is that with careful monitoring of kidney function and prevention of infection with antibiotics, PleurX catheters will be safe, cost-effective and improve quality of life and nutritional status compared to the standard of care.
Detailed Description
Ascites not manageable by diuretic therapy occurs in at least 10% of patients with cirrhosis. Two major options for management include intermittent large volume paracentesis (LVP) and placement of a transjugular intrahepatic portosystemic shunt (TIPS). Unfortunately, not all patients are candidates for TIPS. Those unable to receive TIPS or transplant are left with LVP as the only long-term treatment option. Non-TIPS candidates who are listed for transplant require LVP as a bridge to transplant.
LVP is performed by inserting a non-tunnelled drain, removing ascites fluid via, replacing ascites fluid losses >5 litres(L) with albumin, removing the drain. It can be associated with pain, bleeding, leakage from the site and frequent hospital visits. In between the drains, living with ascites can negatively affect quality of life, particularly the physical discomfort and limitation component scales. In addition, patients with tense ascites have lower protein intake and are more malnourished than those without. Fluid removal improves gastric accommodation.
Indwelling ascites drains are routinely used in patents with malignant ascites. Data evaluating indwelling drains in patients with cirrhosis is limited. One of the reasons that this may not have been explored as a therapeutic option is the potential for infection. As opposed to malignant ascites, cirrhotic ascites generally has a low protein content, a known risk factor for development of spontaneous bacterial peritonitis (SBP). From available data, infection rates in cirrhotic patients with tunnelled drains, not on antibiotic prophylaxis are estimated at 10%. Infection rates on antibiotic prophylaxis would be expected to be lower, but this remains unstudied. Other concerns particular to the patient with cirrhosis are renal dysfunction and acute kidney injury. Limitation of the amount of ascites that is drained to <5L per time and infusion of albumin 8grams(g)/L removed for amounts drained >5L has shown benefit in preventing post paracentesis circulatory and renal dysfunction.
Therefore, as some patients with cirrhosis will be left with intermittent LVP as their only option for management, and as this therapy has implications for quality of life (QOL), worsening nutritional status and cost, we propose an evaluation of an indwelling tunnelled PleurX catheter as an alternative therapeutic option. In this prospective uncontrolled pilot study, the hypothesis is that use of indwelling drains with careful monitoring of renal function and prophylaxis with antibiotics, will be safe, cost-effective and improve quality of life and nutritional status compared to the standard of care.
METHODS:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cirrhosis (based on imaging, liver function test abnormalities, biopsy, or portal hypertension associated complications)
- •Refractory or resistant ascites
- •Not a candidate for TIPS (hospital admissions for encephalopathy, Model for End Stage Liver Disease (MELD) ≥18, diastolic dysfunction (defined as E/A ratio <1 on echocardiogram), patient declined, advanced age, renal disease)
- •Requiring large volume paracentesis ≥twice/month
Exclusion Criteria
- •Malignant ascites due to peritoneal carcinomatosis (requires positive fluid cytology)
- •Patient unwilling to let home care staff enter home
- •Patient unwilling to have intravenous albumin
- •Patient unwilling to have drain placed
- •Patients post liver transplant
- •multi-loculated ascites
Outcomes
Primary Outcomes
Ascites Symptom Inventory (ASI-7)
Time Frame: Change from baseline to 6 months
Includes 7 symptom questions, scored on a Likert scale of 0-4 where 0 is 'does not apply at all' and 4 is 'very strongly applies'
Secondary Outcomes
- Model for End Stage Liver Disease - Sodium (MELD-Na) score(Change from baseline to 6 months)
- Council on Nutrition Appetite Questionnaire (CNAQ)(Change from baseline to 6 months)
- Visual Analog Pain scale(Change from baseline to 6 months)
- Level of serum creatinine(Change from baseline to 6 months)
- Level of serum albumin(Change from baseline to 6 months)
- Cost of care(Change from baseline to 6 months)
- Edmonton Symptom Assessment System-revised version (ESAS-R)(Change from baseline to 6 months)
- Total calorie and protein intake(Change from baseline to 6 months)
- Chronic Liver Disease Questionnaire (CLDQ)(Change from baseline to 6 months)
- Child Pugh score(Change from baseline to 6 months)