NCT03027635

PEriToneal Catheter Versus Repeated Paracentesis for Ascites in Cirrhosis

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Nina Kimer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DEVICE	PleurX, peritoneal tunnelated catheter	A permanent catheter
DEVICE	Large Volume Paracentesis	Short time drainage
DRUG	Ciprofloxacin 500Mg Tablet	SBP prophylaxis

Timeline

• Start date: 2017-01-20
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2017-01-23
• Last updated: 2019-05-20

Locations

1 site across 1 country: Denmark