Liver Cirrhosis, NSBB, TIPS, Variceal Hemorrhage
Conditions
Brief summary
Variceal bleeding (VB) is a life-threatening complication of cirrhosis with a 6-week mortality of approximately 15%-20%. The 1-year rate of recurrent VB is approximately 60% in patients without prophylaxis treatment. Therefore, all patients who survive VB must receive active treatments to prevent rebleeding. Usually, these patients are submitted to rebleeding prophylaxis with endoscopic band ligation (EBL) combined with non-selective beta-blockers (NSBB). Transjugular intrahepatic portosystemic shunts (TIPS) are reserved for those who failed endoscopic plus medical treatment. A recent meta-analysis comparing combination therapy to monotherapy with EBL or drug therapy has demonstrated that combination therapy is only marginally more effective than NSBB alone. This suggests that NSBB is the cornerstone of combination therapy. The lowest rebleeding rates are observed in patients on secondary prophylaxis who are hepatic venous pressure gradient (HVPG) responders (defined as a reduction in HVPG below 12 mm Hg or \> 20% from baseline). A recent study demonstrated that patients who have their first episode of variceal bleeding while on primary prophylaxis with NSBB have an increased risk of further bleeding and death, despite adding EBL. These patients possibly require alternative treatment approaches, such as TIPS. The aim of the present study was to compare the effect of TIPS vs. EBL + NSBB for the prevention of rebleeding in NSBB non-responder for primary prophylaxis.
Interventions
PROCEDURETransjugular intrahepatic portosystemic shunts
Transjugular intrahepatic portosystemic shunt (TIPS) is a procedure that uses imaging guidance to connect the portal vein to the hepatic vein in the liver. A small metal device called a stent is placed to keep the connection open and allow it to bring blood draining from the bowel back to the heart. TIPS may successfully reduce internal bleeding in the stomach and esophagus in patients with cirrhosis and may also reduce the accumulation of fluid in the abdomen (ascites).
OTHERNonselective β-blocker (NSBB)+ endoscopic band ligation (EBL)
Combination therapy of nonselective β-blocker (NSBB) and endoscopic variceal ligation (EBL) will be used for participants in this group. NSBB, which will be titrated to the maximum tolerated dose aiming to decrease the heart rate by 25%, with a lower limit of 50 beats per minute, was started at day 5 after the index bleeding, unless a contraindication was present (severe arrhythmia, severe obstructive chronic obstructive pulmonary disease, or known intolerance). Endoscopic variceal ligation sessions started 2 weeks after the index bleeding and were performed every 2-4 weeks thereafter until eradication of varices, followed by endoscopic surveillance and retreatment, if indicated, every 6-12 months.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of liver cirrhosis * Standard NSBB therapy was used for primary prophylaxis * At least 5 days after index variceal bleeding * Child-Pugh score \<13, Model for end-stage liver disease score \< 19
Exclusion criteria
* Gastric variceal bleeding (GOV2，IGV1，IGV2) * History of shunt surgery * Degree of portal vein thrombosis \> 50% * Refractory ascites * Budd-Chiari syndrome * Hepatocellular carcinoma or other malignant tumors * Uncontrolled infection * HIV * Pregnant or breast-feeding woman * Poor compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of clinically significant variceal rebleeding | 12 months | Recurrent melena or hematemesis resulting in either hospital admission, blood transfusion, drop in hemoglobin of at least 3 g/L, or death within 6 weeks after rebleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of all cause mortality | 12 months | Including liver related and non-liver related death |
| Cumulative incidence of hepatic encephalopathy (HE) | 12 months | HE was evaluated and classified according to West-Haven criteria |
| Cumulative incidence of variceal bleeding related mortality | 12 months | Death due to variceal bleeding |
| Cumulative incidence of adverse events (AE) | 12 months | All kinds of adverse events |
Contacts
Primary ContactJun Tie, Professor
Backup ContactHui Chen, M.D.,Ph.D.
Outcome results
None listed