PEriToneal Catheter Versus Repeated Paracentesis for Ascites in Cirrhosis

• Status: Terminated
• Trial end date: 2019-05-15
• Target enrollment: 0
• Participant gender: All

Summary

Insertion of a tunnelated peritoneal catheter (PleurX) allows repeated intermittent small volume fluid drainage at home. The treatment may improve the management of ascites and have a beneficial effect on the quality of life.

This study aims to evaluate the beneficial and harmful effects of the peritoneal catheter (PleurX) versus repeated large volume paracentesis for patients with cirrhosis and diuretic resistant ascites.

The trial is an investigator initiated, randomised, single blind, parallel arm, controlled trial.

Tunnelated peritoneal (PleurX) catheter versus large volume paracentesis. All patients will receive ciprofloxacin to prevent spontaneous bacterial peritonitis.

We will include 32 adult patients with cirrhosis Duration of trial 18 months. The total duration of follow up is six months. The primary outcome is paracentesis free survival.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nina Kimer
• Treatments: Ciprofloxacin; Diuretics

Criteria

Inclusion Criteria:

• Cirrhosis of any aetiology

• Diuretic resistant ascites defined as i) an inability to mobilise ascites (minimal or no weight loss) despite administration with the maximum tolerable doses of oral diuretics or a daily dose of spironolactone 400 mg and re-accumulation of fluid after therapeutic paracentesis within two weeks or ii) diuretic-related complications including (but not limited to) azotemia, hepatic encephalopathy, or progressive electrolyte imbalances

• Able to read and understand Danish

• Signed and dated informed consent form

• Willing to comply with all study procedures and be available for the duration of the study

• Male or female of any age

• Age at least 18 years

• Expected survival at least three months.

Exclusion Criteria:

• Participants eligible and listed for TIPS

• Serum creatinine levels above 135 umol/L

• Overt hepatic encephalopathy in the two weeks before randomization

• Ascites due to other causes than cirrhosis such as: malignant disease, congestive heart failure, end-stage renal disease, pancreatitis, or Budd-Chiari (hepatic vein thrombosis), or chylous ascites

• Ongoing intra-abdominal infection (peritonitis) or active systemic or local infections, such as urinary tract infection or pneumonia

• Participation in a clinical study that may interfere with participation in this study;

• Evidence of extensive ascites loculation

• Coagulopathy

• Variceal bleeding within two weeks before randomisation

• Intraabdominal surgery within four months before randomisation

• Spontaneous bacterial peritonitis (neutrophil count>250/µl within 24 hours of randomization)

• Patients with an increased risk of procedure related complications as judged by the primary healthcare provider