Bleeding Varices, Decompensated Cirrhosis
Conditions
Keywords
transjugular intrahepatic portosystemic shunt, TIPS, variceal bleeding, liver cirrhosis, hepatitis B
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.
Interventions
PROCEDURETIPS treatment
1. 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. 2. 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. 3. After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted.
DRUGMedical treatment
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.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of survival without liver transplantation | 2 years |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed