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Multicentre, open, randomised, and controlled trial conducted in patients diagnosed with recurrent/refractory ascites who meet inclusion/exclusion criteria. The efficacy of the Alfapump, TIPS and paracentesis with regard to the treatment of ascites will be compared. All patients will receive medical care for cirrhosis and ascites according to the institution's standards of care. Standard of care may include, but is not limited to the administration of diuretics, paracentesis and consideration for orthotopic liver transplantation.
Full description
The study will include patients with decompensated liver cirrhosis and recurrent or refractory, with regular requirements for large volume paracentesis (see subject inclusion criteria). With respect to TIPS-contraindications patients will be assigned to two substudies. If no TIPS-contraindications exists (sub-study 1) patients will be randomized to Alfapump or TIPS. The presence of at least one TIPS-contraindication (sub-study 2) is leading to a randomization to Alfapump or standard of care. All patients will receive medical care for cirrhosis and ascites according to the institution's standards medical care. Standard of care may include, but is not limited to, administration of diuretics, paracentesis and consideration for orthotopic liver transplantation.
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Inclusion criteria
Exclusion criteria
General contraindications indicating an advanced stage of liver cirrhosis:
Gastrointestinal haemorrhage during the last 7 days before inclusion
Renal failure defined as serum creatinine higher than or equal to 1,5 mg/dl at time of inclusion
Clinical evidence of recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks before inclusion.
Clinical evidence of recurring urinary infections, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks before inclusion.
Clinical evidence of loculated ascites.
Residual urinary volume exceeding 100 ml if obstructive uropathy is known or suspected
Known bladder anomaly which might contraindicate implantation of the device.
Known or suspected hepatic or extra hepatic malignancy, unless adequately treated and in complete remission for ≥ 3 years
Known active chronic hepatitis C (unless adequately treated, i.e no Virus-RNA detectable after cessation of antiviral treatment)
Acute peritonitis
Pregnant or nursing women. (A serum pregnancy test is required for fertile women within two years of their last menstruation.)
Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implantation, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial
Suspected lack of compliance
Patients enrolled in another interventional clinical study
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15 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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