Early TIPS With Polytetrafluoroethylene (PTFE) Covered Stents for Acute Variceal Bleeding in Patients With Advanced Cirrhosis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether early use of transjugular intrahepatic portosystemic shunt (TIPS) with Polytetrafluoroethylene (PTFE) covered stents is able to prolong the survival in patients with advanced cirrhosis and acute variceal bleeding.

Official Title
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Early Transjugular Intrahepatic Portosystemic Shunt With Polytetrafluoroethylene Covered Stents Versus Standard Medical Therapy for Acute Variceal Bleeding in Patients With Advanced Cirrhosis

Conditions
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Decompensated Cirrhosis, Bleeding Varices

Intervention / Treatment
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* Procedure: TIPS treatment
* Drug: Medical treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of cirrhosis (clinical or by liver biopsy) Admission due to acute bleeding from oesophageal or gastric (GOV1 or GOV2) varices Child-Pugh Class C (Child-Pugh score less than or equal to 13) or Child-Pugh class B Signed written informed consent Exclusion Criteria: Patients not fulfilling inclusion criteria Pregnancy or breast-feeding Confirmed hepatocellular carcinoma Creatinine greater than 3 mg/dl Terminal hepatic failure (Child-Pugh score greater than 13) Previous treatment with TIPS or combined pharmacological and endoscopic treatment to prevent rebleeding Fundal or ectopic gastric variceal bleeding (IGV1 or IGV2) Complete portal vein thrombosis or portal cavernoma Congestive heart failure New York Heart Association (NYHA) greater than III or medical history of pulmonary hypertension Spontaneous recurrent hepatic encephalopathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIPS treatment<br>Initial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.TIPS will be performed as soon as possible once the patients are enrolled in the study, always within the first 72 hours after the diagnostic endoscopy (preferably in the first 24 hours).Vasoactive drugs will be continued until the TIPS is performed and antibiotics will be continued for 5-7 days. | Procedure: TIPS treatment<br>* A 8 mm Fluency stent will be used. The aim will be to reduce the portal pressure gradient (PPG) below to 12 mm Hg or 25-75% of baseline. Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of large portosystemic collaterals feeding the varices. After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted.<br>* Other names: Transjugular intrahepatic portosystemic shunt (TIPS);|
| Active Comparator: Medical treatment<br>Initial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.Patients will be treated with non-selective beta-blockers (propranolol)on day 5. In case of contraindications or intolerance to beta-blockers, patients will not receive pharmacological treatment (beta-blockers) and the only treatment to prevent rebleeding will be endoscopic band ligation. | Drug: Medical treatment<br>* Patients will receive vasoactive drugs up to 5 days; then a non-selective beta-blocker (propranolol) will be started with an initial dose of 40 mg, the dose of propranolol will be increased/decreased step by step to achieve a baseline heart rate of 55 bpm, or 25% reduction of basal heart rate or up to the maximum tolerated dose of propranolol. The second elective session of endoscopic band ligation will be performed within the first 7-14 days after the initial endoscopic treatment. The following sessions will be performed at 14 +/- 3 days intervals until variceal eradication. Once eradication is achieved, endoscopic monitoring will be performed every 6 months. If varices reappear, new band ligation will be performed.<br>* Other names: Non-selective beta blocker + Endoscopic variceal ligation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of survival without liver transplantation |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants failed to control acute variceal bleeding within 5 days, 6 weeks and 1 year |  | 1 years | 
| Number of bleeding related death |  | 2 years | 
| Number of other portal hypertension related complications on follow-up (ascites, hepatorenal syndrome, hepatic encephalopathy) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transjugular intrahepatic portosystemic shunt, TIPS, variceal bleeding, liver cirrhosis, hepatitis B