TIPS vs. NSBB Plus Endotherapy for the Prevention of Variceal Rebleeding in NSBB Non-responders of Primary Prophylaxis
- Conditions
- NSBBTIPSVariceal HemorrhageLiver Cirrhosis
- Interventions
- Procedure: Transjugular intrahepatic portosystemic shuntsOther: Nonselective β-blocker (NSBB)+ endoscopic band ligation (EBL)
- Registration Number
- NCT04207398
- Lead Sponsor
- Air Force Military Medical University, China
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 114
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TIPS Transjugular 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. NSBB+EBL Nonselective β-blocker (NSBB)+ endoscopic band ligation (EBL) Participants randomized to this group will receive the combination therapy of non-selective beta-blocker (NSBB) and endoscopic band ligation (EBL) . NSBB, including propranolol and carvidilol, will be started at day 5 after the index bleeding and elective EBL sessions started 2 weeks after the index bleeding.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 all cause mortality 12 months Including liver related and non-liver related death
Cumulative incidence of adverse events (AE) 12 months All kinds of adverse events