Early Transjugular Intrahepatic Portosystemic Shunt With Polytetrafluoroethylene Covered Stents Versus Standard Medical Therapy for Acute Variceal Bleeding in Patients With Advanced Cirrhosis
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Air Force Military Medical University, China
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Number of survival without liver transplantation
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
TIPS treatment
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.
Intervention: TIPS treatment (Procedure)
Medical treatment
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.
Intervention: Medical treatment (Drug)
Outcomes
Primary Outcomes
Number of survival without liver transplantation
Time Frame: 2 years
Secondary Outcomes
- 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)
Investigators
Guohong Han
Head of Department of Digestive Interventional Radiology
Air Force Military Medical University, China