Tunneled Peritoneal Catheter for Refractory Ascites in Cirrhosis: A Randomized Case-Series

Abstract

Background and objectives: Refractory ascites markedly worsens prognosis in cirrhosis. Large volume paracentesis (LVP) is standard treatment, but complications are common. In a randomized controlled case-series, we assessed a permanent tunneled peritoneal catheter versus LVP in patients with cirrhosis and ascites. Materials and Methods: Random allocation was computer-generated, and concealment used opaque envelopes. Patients were included from 01-2017 to 12-2018. Inclusion criteria were cirrhosis and recurrent ascites and expected survival of more than 3 months. Results: Thirteen patients were enrolled (PleurX =6 versus LVP =7). Seven were female, age range 51 to 80 years. No procedure-related complications occurred. Two patients died due to variceal bleeding (PleurX-group) and sepsis (LVP-group). One patient was withdrawn due to hyponatremia (PleurX-group). Two patients were withdrawn due to bacterial peritonitis and infection of unknown origin (Control-group). In the PleurX-group, all patients colonized the catheter, two developed bacterial peritonitis. The most common bacterial colonization was Staph. Epidermidis (n=4). Conclusions: In selected patients, the PleurX catheter mobilizes ascites and may be an alternative to LVP. The risk of infection should be considered in each case. The impact of colonization and risk of infections needs further investigation. Trial Registration: EudraCT: CIV-16-10-017324; clinicaltrials.gov: NCT 03027635; Scientific Ethics Committee journal no: H-1604179

Editorial: Percutaneous placement of a permanent tunnelled catheter for patients with non‐malignant ascites—Is it safe?

“…Two studies have attempted to address this issue using a randomised trial design but both were terminated early. 6,7 One study was published and reported a high risk of peritonitis when patients in the permanent catheter group were assessed in a systematic fashion. 7 The large retrospective study by Tergast et al evaluated the use of permanent tunnelled catheters (PleurX™).…”

“…6,7 One study was published and reported a high risk of peritonitis when patients in the permanent catheter group were assessed in a systematic fashion. 7 The large retrospective study by Tergast et al evaluated the use of permanent tunnelled catheters (PleurX™). 8 The PleurX is not approved for non-malignant ascites.…”

“…The combined evidence was of low quality and the safety of the intervention remains uncertain. Two studies have attempted to address this issue using a randomised trial design but both were terminated early 6,7 . One study was published and reported a high risk of peritonitis when patients in the permanent catheter group were assessed in a systematic fashion 7 …”