PEriToneal Catheter Versus Repeated Paracentesis for Ascites in Cirrhosis (PETRA)

Tunnelated Peritoneal Catheter Versus Repeated Large Volume Paracentesis for Diuretic Resistant Ascites in Patients With Cirrhosis: An Investigator Initiated, Open, Parallel Arm Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Cirrhosis; Ascites Hepatic; Ascites (Non-Malignant)
• Intervention / Treatment: Device: PleurX, peritoneal tunnelated catheter; Drug: Ciprofloxacin 500Mg Tablet; Device: Large Volume Paracentesis

Detailed Description

Ten percent of patients with cirrhosis develop ascites. In 90% of patients, ascites can be treated with diuretics. The management of the remaining 10% with diuretic resistant ascites is challenging. Symptoms including abdominal pain, dyspnoea, nausea, vomiting, and anorexia have a detrimental impact on the quality of life. Repeated large volume paracentesis provides only temporary improvement of symptoms.

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.

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.

Investigator initiated, randomised, single blind, parallel arm, controlled trial.

Due to the nature of the intervention and the primary outcome measure, Investigators are unable to conduct the trial with blinding of the patients, the investigators or use blinded outcome assessment.

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

The study investigators will include 32 adult patients with cirrhosis of any aetiology and diuretic resistant ascites.

Gastrounit, Hvidovre University Hospital, Department of Gastroenterology and Hepatology, Odense University Hospital, Department of Gastroenterology and Hepatology, Aarhus University Hospital, and Centre for Hepatology, UCL Institute for Liver and Digestive Health, Royal Free Campus, University College London, UK 18 months. The total duration of follow up is six months. The primary outcome is paracentesis free survival. Secondary outcomes include cumulative number of paracentesis, cirrhosis-related complications, safety, quality of life, changes in metabolic and nutritional parameters, circulatory dysfunction, renal function, cardiac output, neuro-humoral changes.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Danmark
    • Hvidovre, Danmark, Denmark, 2650
      • Gastro Unit, medical Division, University Hospital Hvidovre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PleurX; The PleurX catheter is a tunnelated peritoneal catheter, designed for permanent placement in the peritoneal cavity. The catheter is placed by a physician under sterile conditions. Drainage of ascites is done using vacuum bottles connected to the catheter. This can be managed by a home nurse or the patient.	Device: PleurX, peritoneal tunnelated catheter; A permanent catheter; Drug: Ciprofloxacin 500Mg Tablet; SBP prophylaxis
Active Comparator: Large Volume Paracentesis; Large volume paracentesis is performed in sterile technique, a small incision is made through the skin, and a catheter is inserted through muscle and peritoneum. After the procedure, the patient remains in hospital for observation until the fluid is drained.	Drug: Ciprofloxacin 500Mg Tablet; SBP prophylaxis; Device: Large Volume Paracentesis; Short time drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to first paracentesis	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number of AEs in groups	18 months
Nutritional Status	Indirect calorimetry	18 months
Renal function	glomerular filtration rate	18 months
Cardiac Output	cardiac output	18 months

Collaborators and Investigators

• Sponsor: Nina Kimer

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2017
• Primary Completion (Actual): May 15, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: January 20, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Paracentesis; PleurX; diuretic resistant ascites; Peritoneal tunnelated catheter
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Ascites; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: PETRA21042016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Due to Danish Legislation only anonymized data may be available upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No