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

NCT02612519 | Terminated DMC

• 1 other identifier: Agua-Trial
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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.

• 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.

• 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.

• Cumulative Incidence of device abandonment

  Starts with randomisation and ends after 24 months or when transplant or death occurs before.

• Volume of ascites removed

  Starting four weeks after study inclusion and ending after 24 months or when transplant or death occurs before.

Study Arms (4)

Alfapump - Substudy 1

EXPERIMENTAL

Alfapump implantation

Device: Alfapump

TIPS - Substudy 1

ACTIVE COMPARATOR

TIPS implantation

Device: TIPS

Alfapump - Substudy 2

EXPERIMENTAL

Alfapump implantation

Device: Alfapump

Standard - Substudy 2

NO INTERVENTION

Standard treatment

Interventions

Alfapump DEVICE

Implantation of Alfapump

Alfapump - Substudy 1; Alfapump - Substudy 2

TIPS DEVICE

Implantation of TIPS

TIPS - Substudy 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhosis of the liver
• Recurrent or refractory ascites
• Age ≥ 18 years (at informed consent)
• Written informed consent
• Expected ability to operate the Alfapump device

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (3)

Medizische Klinik III

Aachen, 52074, Germany

Location

Medizinische Klinik und Poliklinik 1 - Gastroenterologie

Dresden, 01307, Germany

Location

Uniklinik Leipzig

Leipzig, 04103, Germany

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Thomas Berg, Prof. Dr.

  Uniklinik Leipzig Sektion Hepatologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 23, 2015
• Study Start: November 1, 2015
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

DE (3)