Clinical Trials Logo

Clinical Trial 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 %.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02016196
Study type Interventional
Source University Hospital, Toulouse
Contact
Status Completed
Phase Phase 3
Start date September 2013
Completion date July 2017

See also
  Status Clinical Trial Phase
Completed NCT01884415 - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis Phase 3
Recruiting NCT05014594 - Sodium-glucose Linked Transporter 2 (SGLT-2) Inhibitors in Recurrent Ascites: a Pilot RCT Phase 2
Not yet recruiting NCT03631147 - The Effect of Rifaximin on Portal Vein Thrombosis N/A
Completed NCT04939350 - Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021
Completed NCT02528760 - To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis N/A
Recruiting NCT05484206 - Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 Phase 1
Not yet recruiting NCT05538546 - Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
Not yet recruiting NCT04053231 - Hepatocarcinoma Recurrence on the Liver Study - Part2
Recruiting NCT02983968 - Use of the French Healthcare Insurance Database
Completed NCT02705534 - Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 Phase 3
Completed NCT02596880 - Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics Phase 3
Completed NCT02247414 - Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection Phase 4
Withdrawn NCT01956864 - Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer Phase 1
Completed NCT01447537 - Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis N/A
Completed NCT02113631 - Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir N/A
Completed NCT01362855 - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Active, not recruiting NCT01205074 - ¹³C-Methacetin Breath Test (MBT) Methodology Study Phase 2/Phase 3
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01231828 - Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. N/A
Terminated NCT00375011 - Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics