IA Trial Radar | ||
|---|---|---|
L'essai clinique NCT06576934 (eTIPS) pour Cirrhose du foie, Ascite hépatique, Hypertension portale est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
Un essai clinique correspond aux filtres sélectionnés
Vue en carte
Early TIPS in Patients With Liver Cirrhosis and Ascites (eTIPS) 134
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT06576934 (eTIPS) est une étude interventionnel pour Cirrhose du foie, Ascite hépatique, Hypertension portale. Son statut actuel est : en recrutement. L'étude a débuté le 1 avril 2025 et vise à recruter 134 participants. Dirigée par University Hospital Freiburg, l'étude devrait être terminée d'ici le 15 février 2029. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 10 avril 2025.
Résumé succinct
The aim of this clinical trial is to compare the safety and efficacy of transjugular intrahepatic portosystemic shunt (TIPS) implantation with standard treatment (diuretic medications, and if necessary, paracenteses) in patients with liver cirrhosis and development of ascites as the first decompensating event.
By creating a shunt between the liver vein and the portal vein, blood is diverted from the portal vein dire...
Afficher plusDescription détaillée
Complications in patients with liver cirrhosis are mainly due to the development of clinical significant portal hypertension. These complications include development of varices and ascites. Implantation of a transjugular intrahepatic portosystemic shunt (TIPS) has emerged as a safe and effective interventional treatment of portal hypertension. TIPS implantation is recommended for secondary prophylaxis of variceal ble...Afficher plus
Titre officiel
Early Implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) in Patients With Liver Cirrhosis and Ascites: a Multicentre, Randomised Controlled Trial
Pathologies
Cirrhose du foieAscite hépatiqueHypertension portalePublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- eTIPS
Numéro NCT
Date de début (réel)
2025-04-01
Dernière mise à jour publiée
2025-04-10
Date de fin (estimée)
2029-02-15
Inscription (estimée)
134
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
liver cirrhosis
Transjugular intrahepatic portosystemic shunt
ascites
MELD
Transjugular intrahepatic portosystemic shunt
ascites
MELD
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalTransjugular intrahepatic portosystemic shunt (TIPS) Patients will receive TIPS implantation if ascites as the first single decompensating event with grade 2 ascites and MELD ≥ 15 OR grade 3 ascites occurs. | Transjugular intrahepatic portosystemic shunt (TIPS) TIPS implantation is performed by creating a shunt between the liver vein and the portal vein to enable portal pressure reduction. |
Aucune interventionStandard medical treatment Patients in this group will receive standard medical treatment according to the current EASL guidelines (salt restriction, diuretic treatment, carvedilol, large-volume paracentesis if necessary, albumin substitution if more than 5 litre of ascites is removed) | N/A |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Transplantation-free survival (TFS) | The primary objective of this study is to assess a survival benefit in patients with early allocation to TIPS implantation in comparison to patients with standard medical treatment (SMT). | Through study completion, an average of 12 months |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Time to ascites with need for paracenteses | Assessment of the duration until the next paracentesis after randomisation occurs to compare the efficacy of TIPS implantation compared to standard medical treatment. | Through study completion, an average of 12 months |
Assessment of quality of life | Quality of life assessed with the SF-36 and CLDQ (chronic liver disease questionnaire) before TIPS implantation/study inclusion, 6 and 12 months after randomisation. | Through study completion, an average of 1 year: at study inclusion, at 6 and 12 months after randomisation |
Rate of TIPS implantation in the standard medical treatment group | Need for TIPS implantation (recurrent ascites or variceal bleeding) in the standard medical treatment group. | Through study completion, an average of 12 months |
Rate of TIPS dysfunction | Development of TIPS dysfunction in the TIPS group | Through study completion, an average of 12 months |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
Patients eligible for inclusion in this trial must meet all of the following criteria:
- Patients ≥ 18 years and < 80 years
- Liver cirrhosis as documented by previous liver biopsy or by a combination of typical clinical, biochemical and sonographic features
- Ascites as the first single decompensating event with grade 2 ascites and MELD ≥ 15 OR grade 3 ascites
- INR ≤ 1.5
- Ability to understand the nature of the trial and the trial related procedures and to comply with them
Patients eligible for this trial must not meet any of the following criteria:
- Treatment refractory or recurrent ascites at the time of study inclusion
- Patients with concomitant variceal bleeding fulfilling the criteria for pre-emptive TIPS implantation (Child-Pugh class C < 14 points or Child-Pugh class B >7 with active bleeding at initial endoscopy or hepatic venous pressure gradient \[HVPG\] > 20 mmHg at the time of bleeding)
- Budd-Chiari syndrome
- Portal vein thrombosis (PVT)
- Spontaneous bacterial peritonitis (SBP)
- Uncontrolled systemic infection (defined as an increase of > 20% if inflammatory parameters \[C-reactive protein, procalcitonin, leukocytes\] and/or sepsis as a reason for development of ascites
- Cardiac cirrhosis (defined as the development of liver cirrhosis in a patient with cardiac heart failure due to primary cardiac disease)
- Clinical significant cardiac disease (NYHA ≥II)
- Untreated valvular heart disease: middle to high-grade valve stenosis or insufficiency (applies to mitral, tricuspid, aortic and pulmonary valves)
- Diastolic dysfunction grade III, stated by transthoracic echocardiogram (TTE)
- Reduced left ventricular ejection fraction ≤50%
- Pulmonary hypertension (mean pulmonary arterial pressure > 45 mmHg)
- Bilirubin > 3 mg/dl
- Obstructive cholestasis
- Hepatorenal syndrome type AKI (HRS-AKI)
- Acute on chronic liver failure
- Benign liver tumor within the potential puncture tract
- Patient after liver transplantation
- Prior TIPS implantation
- Ongoing and/or recurrent hepatic encephalopathy (grade >II)
- Active tumor disease including hepatocellular carcinoma defined as need for chemotherapy, radiation therapy, interventional or surgical treatment
- New onset of antiviral treatment for chronic hepatitis B virus (HBV) infection within the last 3 months
- Untreated chronic hepatitis C virus (HCV) infection
- Life expectancy <1 year
- Pregnant or breastfeeding women
- Patients without the legal capacity who are unable to understand the nature, significance and consequences of the study
- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- Person who is in a relationship of dependence/employment with the sponsor or the investigator
University Hospital Freiburg- 🏥Jena U...
Partie responsable de l'étude
Prof. Dr. Dominik Bettinger, Investigateur principal, Principal Investigator, University Hospital Freiburg
Contact central de l'étude
Contact: Dominik Bettinger, MD, +4976127036870, [email protected]
Contact: Marco Janoschke, PhD, +4976127077831, [email protected]
1 Centres de l'étude dans 1 pays
University Medical Center Freiburg, Freiburg im Breisgau, 79106, Germany
Dominik Bettinger, Prof. Dr., Contact, +4976127036870, [email protected]
En recrutement