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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 %.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rifaximin | Experimental | 6 rifaximin caps of 200 mg per day morning and night, during 15 days before TIPS, and after TIPS during 6 months. |
|
| placebo | Placebo Comparator | 6 caps placebo morning and night, 15 days before and 6 months after TIPS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | 6 rifaximin caps of 200 mg morning and night, 15 days before and 6 months after TIPS -------------------------------------------------------------------------------- |
| Measure | Description | Time Frame |
|---|---|---|
| First episode of overt encephalopathy in patients treated by TIPS | First episode of overt encephalopathy in patients treated by TIPS | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of hospitalisation days | Number and days of hospitalisations for encephalopathy | 6 months |
| Frequency of kidney insufficiency | number of digestive bleeding follow up to portal hypertension, number of ascit punctions, frequency kidney insufficiency and hepatocellular carcinoma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Bureau, MD PhD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHToulouse | Toulouse | France | 31059 | France | ||
| CHU Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33524293 | Result | Bureau C, Thabut D, Jezequel C, Archambeaud I, D'Alteroche L, Dharancy S, Borentain P, Oberti F, Plessier A, De Ledinghen V, Ganne-Carrie N, Carbonell N, Rousseau V, Sommet A, Peron JM, Vinel JP. The Use of Rifaximin in the Prevention of Overt Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt : A Randomized Controlled Trial. Ann Intern Med. 2021 May;174(5):633-640. doi: 10.7326/M20-0202. Epub 2021 Feb 2. | |
| 37467180 |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| placebo | Drug | 6 placebo caps per day morning and night, during 15 days before TIPS and 6 months after TIPS |
|
| 6 months |
| transplants, deaths | - number of transplants and deaths | 6 months |
| intestinal microbiota | Composition of intestinal microbiota in 30 patients (only UHToulouse) | 6 months |
| Angers |
| France |
| Hôpital Jean Verdier | Bondy | France |
| CHU Bordeaux | Bordeaux | France |
| CHRU Lille | Lille | France |
| CHU Marseille | Marseille | France |
| CHU Nantes | Nantes | France |
| CHU Beaujon Clichy | Paris | France |
| CHU Saint-Antoine | Paris | France |
| Pitié Salpêtrière | Paris | France |
| CHU Poitiers | Poitiers | France |
| CHU Rennes | Rennes | France |
| CHU Tours | Tours | France |
| Derived |
| Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2. |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |