Prospective Evaluation of PleurX Drain for Treatment of Cirrhotic Refractory Ascites

NCT04569565 | Completed

• 1 other identifier: Pro00055611
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ascites Hepatic

Outcome Measures

Primary Outcomes (1)

• Ascites Symptom Inventory (ASI-7)

  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'

  Change from baseline to 6 months

Secondary Outcomes (10)

• Model for End Stage Liver Disease - Sodium (MELD-Na) score

  Change from baseline to 6 months

• Level of serum creatinine

  Change from baseline to 6 months

• Council on Nutrition Appetite Questionnaire (CNAQ)

  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

Study Arms (1)

PleurX catheter intervention

EXPERIMENTAL

Participants will undergo placement and follow up monitoring of PleurX catheter.

Device: PleurX catheter

Interventions

PleurX catheter DEVICE

Placement of PleurX catheter for refractory cirrhotic ascites, with follow up monitoring

PleurX catheter intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Becton, Dickinson and Company: collaborator

Related Publications (31)

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Study Officials

• Puneeta Tandon

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Juan G Abraldes

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 30, 2020
• Study Start: May 18, 2016
• Primary Completion: March 20, 2019
• Study Completion: March 20, 2019
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share