TIPS vs. NSBB Plus Endotherapy for the Prevention of Variceal Rebleeding in NSBB Non-responders of Primary Prophylaxis

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Liver Cirrhosis; NSBB; Variceal Hemorrhage; TIPS

Treatments: Procedure: Transjugular intrahepatic portosystemic shunts; Other: Nonselective β-blocker (NSBB)+ endoscopic band ligation (EBL)

Study type: Interventional

Funder types: Other

Identifiers

NCT04207398

KY20192149-C-1

Details and patient eligibility

About

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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

TIPS

Experimental group

Description:

Transjugular intrahepatic portosystemic shunt (TIPS) is a procedure that uses imaging guidance to connect the portal vein to the hepatic vein in the liver.

Treatment:

Procedure: Transjugular intrahepatic portosystemic shunts

NSBB+EBL

Active Comparator group

Description:

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.

Treatment:

Other: Nonselective β-blocker (NSBB)+ endoscopic band ligation (EBL)