A controlled multicentre study comparing early treatment with polytetrafluoroethylene (PTFE) covered stents (Viator) versus optimised medical treatment in patients with cirrhosis and a high risk variceal bleeding episode

Completed

Conditions: iver cirrhosis
Digestive System
Liver cirrhosis

Registration Number: ISRCTN58150114

Lead Sponsor: Individual Sponsor (Spain)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 64

Inclusion Criteria

1. Male and female patients 18 - 75 years of age
2. History of cirrhosis (clinical or by liver biopsy)
3. Admission due to acute bleeding from oesophageal or gastric (GOV1 or GOV2) varices
4. Child-Pugh Class C or Child-Pugh class B plus active bleeding at endoscopy under pharmacological treatment
5. Signed written informed consent

Exclusion Criteria

1. Patients not fulfilling inclusion criteria
2. Pregnancy
3. Confirmed hepatocellular carcinoma with any of the following characteristics:
3.1. One nodule of more than 5 cm
3.2. More than 3 greater than 3 cm
3.3. Perihiliar
4. Creatinine greater than 3 mg/dl
5. Terminal hepatic failure (Child-Pugh score greater than 13)
6. Previous treatment with TIPS or combined pharmacological and endoscopic treatment to prevent rebleeding
7. Fundal or ectopic gastric variceal bleeding (IGV1 or IGV2)
8. Portal vein cavernoma
9. Congestive heart failure New York Heart Association (NYHA) greater than III or medical history of pulmonary hypertension
10. Spontaneous recurrent hepatic encephalopathy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The major end-point of the present project is to evaluate, in patients with high risk of failure to control bleeding, whether early treatment with PTFE covered stents, in comparison with combined pharmacologic and endoscopic treatment, reduces the incidence of the main composed end-point: failure to control acute variceal bleeding or preventing significant variceal rebleeding within 1 year of inclusion.

Secondary Outcome Measures

Name	Time	Method
Secondary end-points: To evaluate differences between these two treatment strategies in relation to:<br>1. The previous major composed end-point plus mortality<br>2. Failure to control acute variceal bleeding, early rebleeding and mortality at 5-days and at 6-weeks<br>3. Variceal rebleeding after day 5<br>4. Survival without liver transplantation<br>5. Bleeding related mortality<br>6. Development of other portal hypertension related complications on follow-up (ascites, hepatorenal syndrome, SBP, hepatic encephalopathy)<br>7. Transfusion requirements, days in hospital and use of alternative treatments over follow-up (5-days, 6-weeks, one-year)<br>8. Cost