Preventing liver complications after TIPS placement with rifaximin and lactulose

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of rifaximin and lactulose in preventing post-TIPS hepatic encephalopathy (HE) in patients undergoing Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement. It is a multicenter, randomized, placebo-controlled, double-blind study involving adult patients with liver cirrhosis who are at risk of developing HE. Participants will receive either the active treatment or a placebo starting 72 hours before the procedure and continuing for three months post-TIPS. The primary outcome will be the incidence of overt HE within three months, assessed using the West Haven criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Elective TIPS placement for refractory ascites or recurrent variceal bleeding:

   Recurrent tense ascites and one or more of the following criteria:

   i. Not responding to the maximal dose of diuretics (400 milligram spironolactone and 160 milligram furosemide).

   ii. Kidney insufficiency (Creatinine \> 135 umol/L) induced by diuretics. iii. Electrolyte disturbances (Sodium \< 125 mmol/L, Potassium \> 5.5 mmol/L) induced by diuretics.

   iv. Not tolerating higher dose of diuretics (e.g. because of subjective side effects like muscle cramps).

   Recurrent variceal bleeding, not responsive to treatment with endoscopic band ligation and beta-blockers, with a high risk of failure of endoscopic treatment:

   i. Patients with a variceal bleeding and Child-Pugh C (10-13 points) cirrhosis or ii. Patients with a variceal bleeding, Child-Pugh B and an active bleeding during endoscopy
2. Age ≥18 years
3. Confirmed liver cirrhosis as documented by liver biopsy, elastography (e.g. Fibroscan) or combination of usual radiological and biochemical criteria.
4. Signed informed consent

Exclusion Criteria:

1. Any absolute contraindications for TIPS placement
2. Use of ciclosporin
3. Life-threatening variceal bleeding with emergency TIPS placement which can not be delayed 72 hours
4. Age \> 80 years
5. Non-cirrhotic portal hypertension
6. Portal vein thrombosis (main trunk)
7. HIV
8. Current or recent (\<3 months) use of rifaximin
9. Overt neurologic diseases such as Alzheimer's disease, Parkinson's disease
10. Pregnant or breastfeeding women
11. Patients refusing or unable to sign informed consent

Where it's running

• Universitaire Ziekenhuizen Leuven
  Leuven, Belgium Recruiting
• Academic Medical Centre
  Amsterdam, Netherlands Recruiting
• University Medical Center Groningen
  Groningen, Netherlands Recruiting
• Leiden University Medical Center
  Leiden, Netherlands Recruiting
• Radboud University
  Nijmegen, Netherlands Recruiting
• Erasmus Medical Center
  Rotterdam, Netherlands Recruiting

Study contacts

• Principal investigator: Bart Takkenberg, MD, PhD — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Study coordinator: Koos de Wit, MD
• Email: leverresearch@amc.uva.nl
• Phone: 0031-20-5668468

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.