An interventional study of Alfapump and TIPS in Liver Cirrhosis, sponsored by University of Leipzig. Terminated at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by University of Leipzig · Not applicable, Interventional, and Treatment
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.
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 15 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
General contraindications indicating an advanced stage of liver cirrhosis:
Alfapump implantation
Device: Alfapump
TIPS implantation
Device: TIPS
Alfapump implantation
Device: Alfapump
Standard treatment
Implantation of Alfapump
Implantation of TIPS
The primary outcome is the (average) number of paracenteses per quarter during time without device abandonment, transplant, or death documented on a time horizon of 4 quarters (i.e.1 year).
Time frame: Starts with randomisation and ends after 12 months or when a device abandonment, transplant, or death occurs before.
Number of paracenteses per quarter during time without device abandonment, transplant, or death documented on a time horizon of 24 months.
Time frame: Starts with randomisation and ends after 24 months or when a device abandonment, transplant, or death occurs before.
Number of paracenteses per quarter during time without transplant or death documented on a time horizon of 24 months.
Time frame: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Transplant-free survival
Time frame: From randomisation to 24 months or to death, censoring patients alive at the date of last information or at the date of orthotopic liver transplantation.
Cumulative Incidence of device abandonment
Time frame: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Volume of ascites removed
Time frame: Starting four weeks after study inclusion and ending after 24 months or when transplant or death occurs before.
Patients Quality of Life (EQ-5D Questionnaire)
Time frame: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Frequency and duration of hospital stays
Time frame: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Nutrition status, assessed by time course of upper arm girth [cm]
Time frame: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Albumin substitution, assessed as total amount per quarter [g].
Time frame: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Cumulative incidence of first occurrence of hepatic encephalopathy Stage 2 or higher
Time frame: Starts with randomisation and ends after 12 months months or when a device abandonment, transplant, or death occurs before.
This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University of Leipzig