Clinical trial NCT04207398: TIPS vs. NSBB Plus Endotherapy for the Prevention of Variceal Rebleeding in NSBB Non-responders of Primary Prophylaxis
Official title: TIPS vs. NSBB Plus Endotherapy for the Prevention of Variceal Rebleeding in NSBB Non-responders of Primary Prophylaxis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Variceal Hemorrhage
TIPS
NSBB
Liver Cirrhosis
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence of clinically significant variceal rebleeding
timeFrame: 12 months
Secondary outcomes:
measure: Cumulative incidence of variceal bleeding related mortality
timeFrame: 12 months
measure: Cumulative incidence of all cause mortality
timeFrame: 12 months
measure: Cumulative incidence of hepatic encephalopathy (HE)
timeFrame: 12 months
measure: Cumulative incidence of adverse events (AE)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: de Souza AR, La Mura V, Reverter E, Seijo S, Berzigotti A, Ashkenazi E, Garcia-Pagan JC, Abraldes JG, Bosch J. Patients whose first episode of bleeding occurs while taking a beta-blocker have high long-term risks of rebleeding and death. Clin Gastroenterol Hepatol. 2012 Jun;10(6):670-6; quiz e58. doi: 10.1016/j.cgh.2012.02.011. Epub 2012 Feb 22.