CompletedNot Applicable

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

China132 participantsStarted 2011-07

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of survival without liver transplantation

Timeframe: 2 years

Trial details

NCT IDNCT01370161

SponsorAir Force Military Medical University, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-30

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