Back to resultsAlfapump System Versus Transjugular Intrahepatic Portosystemic Shunt and Paracentesis in the Treatment of Ascites
Primary Purpose
Liver Cirrhosis
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Alfapump
TIPS
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- Cirrhosis of the liver
- Recurrent or refractory ascites
- Age ≥ 18 years (at informed consent)
- Written informed consent
- Expected ability to operate the Alfapump device
- Alcohol abstinence ≥ 3 months at date of inclusion
Exclusion Criteria:
General contraindications indicating an advanced stage of liver cirrhosis:
- Bilirubin > 5 mg/dl and/or
- INR > 1.5 (without oral anticoagulant such as Vitamin K antagonists or new oral anticoagulants (NOAKs), which inhibit the determination of INR. Therefore patients must be switched to alternative anticoagulants such as heparin or low molecular heparin or fondaparinux that do not interfere with INR measurements) and/or
- Serum-Sodium < 130 mmol/l and/or
- ECOG > 2 (Performance status)
- 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
Sites / Locations
- Medizische Klinik III
- Medizinische Klinik und Poliklinik 1 - Gastroenterologie
- Uniklinik Leipzig
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
No Intervention
Arm Label
Alfapump - Substudy 1
TIPS - Substudy 1
Alfapump - Substudy 2
Standard - Substudy 2
Arm Description
Alfapump implantation
TIPS implantation
Alfapump implantation
Standard treatment
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Number of paracenteses per quarter during time without device abandonment, transplant, or death documented on a time horizon of 24 months.
Number of paracenteses per quarter during time without transplant or death documented on a time horizon of 24 months.
Transplant-free survival
Cumulative Incidence of device abandonment
Volume of ascites removed
Patients Quality of Life (EQ-5D Questionnaire)
Frequency and duration of hospital stays
Nutrition status, assessed by time course of upper arm girth [cm]
Albumin substitution, assessed as total amount per quarter [g].
Cumulative incidence of first occurrence of hepatic encephalopathy Stage 2 or higher
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02612519
Brief Title
Alfapump System Versus Transjugular Intrahepatic Portosystemic Shunt and Paracentesis in the Treatment of Ascites
Official Title
Alfapump System Versus Transjugular Intrahepatic Portosystemic Shunt and Paracentesis in the Treatment of Ascites. A Multicentre Randomised Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
low recruitement rate
Study Start Date
November 2015 (undefined)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alfapump - Substudy 1
Arm Type
Experimental
Arm Description
Alfapump implantation
Arm Title
TIPS - Substudy 1
Arm Type
Active Comparator
Arm Description
TIPS implantation
Arm Title
Alfapump - Substudy 2
Arm Type
Experimental
Arm Description
Alfapump implantation
Arm Title
Standard - Substudy 2
Arm Type
No Intervention
Arm Description
Standard treatment
Intervention Type
Device
Intervention Name(s)
Alfapump
Intervention Description
Implantation of Alfapump
Intervention Type
Device
Intervention Name(s)
TIPS
Intervention Description
Implantation of TIPS
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
Cumulative Incidence of device abandonment
Time Frame
Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Title
Volume of ascites removed
Time Frame
Starting four weeks after study inclusion and ending after 24 months or when transplant or death occurs before.
Title
Patients Quality of Life (EQ-5D Questionnaire)
Time Frame
Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Title
Frequency and duration of hospital stays
Time Frame
Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Title
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.
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cirrhosis of the liver
Recurrent or refractory ascites
Age ≥ 18 years (at informed consent)
Written informed consent
Expected ability to operate the Alfapump device
Alcohol abstinence ≥ 3 months at date of inclusion
Exclusion Criteria:
General contraindications indicating an advanced stage of liver cirrhosis:
Bilirubin > 5 mg/dl and/or
INR > 1.5 (without oral anticoagulant such as Vitamin K antagonists or new oral anticoagulants (NOAKs), which inhibit the determination of INR. Therefore patients must be switched to alternative anticoagulants such as heparin or low molecular heparin or fondaparinux that do not interfere with INR measurements) and/or
Serum-Sodium < 130 mmol/l and/or
ECOG > 2 (Performance status)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Berg, Prof. Dr.
Organizational Affiliation
Uniklinik Leipzig Sektion Hepatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizische Klinik III
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik 1 - Gastroenterologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Uniklinik Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Alfapump System Versus Transjugular Intrahepatic Portosystemic Shunt and Paracentesis in the Treatment of Ascites
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