PEriToneal Catheter Versus Repeated Paracentesis for Ascites in Cirrhosis

NCT ID: NCT03027635

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-20
• Study Completion Date: 2019-05-15

Brief 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.

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.

Conditions

Cirrhosis; Ascites Hepatic; Ascites (Non-Malignant)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PleurX, peritoneal tunnelated catheter

Intervention Type: DEVICE

A permanent catheter

Ciprofloxacin 500Mg Tablet

Intervention Type: DRUG

SBP prophylaxis

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.

Group Type: ACTIVE_COMPARATOR

Large Volume Paracentesis

Intervention Type: DEVICE

Short time drainage

Ciprofloxacin 500Mg Tablet

Intervention Type: DRUG

SBP prophylaxis

Interventions

PleurX, peritoneal tunnelated catheter

A permanent catheter

Intervention Type: DEVICE

Large Volume Paracentesis

Short time drainage

Intervention Type: DEVICE

Ciprofloxacin 500Mg Tablet

SBP prophylaxis

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nina Kimer

OTHER

Sponsor Role: lead

Responsible Party

Nina Kimer

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Gastro Unit, medical Division, University Hospital Hvidovre

Hvidovre, Danmark, Denmark

Countries

Denmark

Other Identifiers

PETRA21042016

Identifier Type: -

Identifier Source: org_study_id