Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS
- Registration Number
- NCT02016196
- Lead Sponsor
- University Hospital, Toulouse
- Brief Summary
TIPS has been used for 20 years, as a means of reducing portal pressure in patients with cirrhosis and portal hypertension related complications. TIPS proved more effective than alternative treatments in controlling or preventing variceal bleeding and refractory ascites. The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy (OHE). Three risk factors for post-TIPS OHE have been identified: age over 65 years, history of previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the incidence of post-TIPS OHE in patients fulfilling these criteria remains close to 35 %.
- Detailed Description
TIPS has been used for 20 years, as a means of reducing portal pressure in patients with cirrhosis and portal hypertension related complications. TIPS proved more effective than alternative treatments in controlling or preventing variceal bleeding and refractory ascites. The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy (OHE). Three risk factors for post-TIPS OHE have been identified: age over 65 years, history of previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the incidence of post-TIPS OHE in patients fulfilling these criteria remains close to 35 %. Furthermore, the pathogenesis of HE in general but also in patients treated by TIPS is still not well understood. Therefore, there is a real challenge in discovering new molecular mechanisms involved in pathogenesis of OHE as well as new treatment to better prevent the risk of OHE in patients treated by TIPS. Observational and experimental studies suggest a microbiota's role in the mechanism of OHE and recently a non absorbable antibiotic has proven to reduce the risk of recurrence of OHE. However, the effect of this drug for the prevention of a first episode of OHE in patients treated by TIPS is not known. In addition, the mechanisms of the beneficial effect of rifaximin remain poorly understood.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 211
- cirrhosis with TIPS for ascit treatment or hydrothorax
- prevention digestive bleeding follow up portal hypertension -
- signed consent
- hepatocellular carcinoma out of Milan criteria or palliative phase cancer
- Child Pugh score > 12
- TIPS indicated for other indication than bellow
- encephalopathy signs : asterixis or confusion
- Hypersensibility to rifaximin, or derivated of rifamycin
- Patients treated by same class antibacterial
- pregnant woman
- Patient with hepatic transplant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo 6 caps placebo morning and night, 15 days before and 6 months after TIPS rifaximin Rifaximin 6 rifaximin caps of 200 mg per day morning and night, during 15 days before TIPS, and after TIPS during 6 months.
- Primary Outcome Measures
Name Time Method First episode of overt encephalopathy in patients treated by TIPS 6 months First episode of overt encephalopathy in patients treated by TIPS
- Secondary Outcome Measures
Name Time Method intestinal microbiota 6 months Composition of intestinal microbiota in 30 patients (only UHToulouse)
transplants, deaths 6 months - number of transplants and deaths
number of hospitalisation days 6 months Number and days of hospitalisations for encephalopathy
Frequency of kidney insufficiency 6 months number of digestive bleeding follow up to portal hypertension, number of ascit punctions, frequency kidney insufficiency and hepatocellular carcinoma
Trial Locations
- Locations (13)
CHU Bordeaux
🇫🇷Bordeaux, France
CHRU Lille
🇫🇷Lille, France
CHU Marseille
🇫🇷Marseille, France
Pitié Salpêtrière
🇫🇷Paris, France
CHU Saint-Antoine
🇫🇷Paris, France
CHU Angers
🇫🇷Angers, France
Hôpital Jean Verdier
🇫🇷Bondy, France
CHU Nantes
🇫🇷Nantes, France
CHU Poitiers
🇫🇷Poitiers, France
CHU Tours
🇫🇷Tours, France
CHU Rennes
🇫🇷Rennes, France
UHToulouse
🇫🇷Toulouse, France
CHU Beaujon Clichy
🇫🇷Paris, France