Alfapump System Versus Transjugular Intrahepatic Portosystemic Shunt and Paracentesis in the Treatment of Ascites

Liver Cirrhosis Clinical Trial

Official title:

Alfapump System Versus Transjugular Intrahepatic Portosystemic Shunt and Paracentesis in the Treatment of Ascites. A Multicentre Randomised Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02612519
• Other study ID #: Agua-Trial
• Status: Terminated
• Phase: N/A
• Start date: November 2015
• Est. completion date: April 30, 2019

Study information

• Verified date: July 2019
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Cirrhosis of the liver

2. Recurrent or refractory ascites

3. Age = 18 years (at informed consent)

4. Written informed consent

5. Expected ability to operate the Alfapump device

6. Alcohol abstinence = 3 months at date of inclusion

Exclusion Criteria:

1. 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)

2. Gastrointestinal haemorrhage during the last 7 days before inclusion

3. Renal failure defined as serum creatinine higher than or equal to 1,5 mg/dl at time of inclusion

4. 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.

5. 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.

6. Clinical evidence of loculated ascites.

7. Residual urinary volume exceeding 100 ml if obstructive uropathy is known or suspected

8. Known bladder anomaly which might contraindicate implantation of the device.

9. Known or suspected hepatic or extra hepatic malignancy, unless adequately treated and in complete remission for = 3 years

10. Known active chronic hepatitis C (unless adequately treated, i.e no Virus-RNA detectable after cessation of antiviral treatment)

11. Acute peritonitis

12. Pregnant or nursing women. (A serum pregnancy test is required for fertile women within two years of their last menstruation.)

13. 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

14. Suspected lack of compliance

15. Patients enrolled in another interventional clinical study

Related Conditions & MeSH terms

• Ascites
• Liver Cirrhosis

Intervention

Device:
• Alfapump
Implantation of Alfapump
• TIPS
Implantation of TIPS

Locations

Country	Name	City	State
Germany	Medizische Klinik III	Aachen
Germany	Medizinische Klinik und Poliklinik 1 - Gastroenterologie	Dresden
Germany	Uniklinik Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Starts with randomisation and ends after 12 months or when a device abandonment, transplant, or death occurs before.
Secondary	Number of paracenteses per quarter during time without device abandonment, transplant, or death documented on a time horizon of 24 months.		Starts with randomisation and ends after 24 months or when a device abandonment, transplant, or death occurs before.
Secondary	Number of paracenteses per quarter during time without transplant or death documented on a time horizon of 24 months.		Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Secondary	Transplant-free survival		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.
Secondary	Cumulative Incidence of device abandonment		Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Secondary	Volume of ascites removed		Starting four weeks after study inclusion and ending after 24 months or when transplant or death occurs before.
Secondary	Patients Quality of Life (EQ-5D Questionnaire)		Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Secondary	Frequency and duration of hospital stays		Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Secondary	Nutrition status, assessed by time course of upper arm girth [cm]		Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Secondary	Albumin substitution, assessed as total amount per quarter [g].		Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Secondary	Cumulative incidence of first occurrence of hepatic encephalopathy Stage 2 or higher		Starts with randomisation and ends after 12 months months or when a device abandonment, transplant, or death occurs before.