Transjugular intrahepatic portosystemic shunt for the prevention of variceal rebleeding in cirrhotic patients with portal vein thrombosis: study protocol for a randomised controlled trial

Abstract

IntroductionPortal vein thrombosis (PVT) increases the risk of variceal rebleeding in liver cirrhosis. However, the strategy for preventing variceal rebleeding in cirrhotic patients with PVT has not been explored. This study aims to evaluate whether the transjugular intrahepatic portosystemic shunt (TIPS) or conventional therapy is preferable for the prevention of variceal rebleeding in liver cirrhosis patients with PVT.Methods and analysisThis is a randomised controlled trial comparing the safety and efficacy of TIPS versus conventional therapy (ie, endoscopic therapy combined with non-selective β-blockers and anticoagulants) for the prevention of variceal rebleeding in cirrhotic patients with non-tumoral PVT. A total of 50 cirrhotic patients with PVT (thrombus >50% of portal vein lumen occupancy) and a history of variceal bleeding will be stratified according to the Child-Pugh class and degree of PVT, and randomised into the TIPS and conventional therapy groups. The primary objective was to compare the incidence of variceal rebleeding between the two groups. The secondary objectives were to compare the overall mortality, variceal rebleeding-related mortality, portal vein recanalisation and complications between the two groups, and to observe the progression of PVT in patients without portal vein recanalisation.Ethics and disseminationThis study was approved by the ethics committee of Xijing hospital (No. 20110224-5), and was registered at ClinicalTrials.gov (NCT01326949). All participants give written informed consent. The first patient was recruited into our study on 4 June 2011. A total of 29 patients were recruited through 5 March 2013 (14 and 15 patients assigned to the TIPS and conventional therapy groups, respectively). If TIPS is superior to conventional therapy for the prevention of variceal rebleeding in cirrhotic patients with PVT, TIPS might be recommended as the first-line therapy in such patients. But a small sample size potentially limits the generalisation of our conclusions.Trial registrationThis study was registered at ClinicalTrials.gov on 29 March 2011. The trial registration number is NCT01326949.Trial statusThe first patient was recruited into our study on 4 June 2011. A total of 29 patients were recruited through 5 March 2013 (14 and 15 patients assigned to the TIPS and conventional therapy groups, respectively).

Transjugular intrahepatic portosystemic shunt for portal vein thrombosis with variceal bleeding in liver cirrhosis: outcomes and predictors in a prospective cohort study

“…No control group was established in this study. However, a randomized controlled trial, which compares the outcome of TIPS with that of pharmacological/endoscopic therapy in combination with anticoagulation for the secondary prophylaxis of variceal bleeding in cirrhotic patients with PVT, is being conducted at our centre . All patients have been successfully enrolled till January 2014, and they are being followed.…”

Association between Portal Vein Thrombosis and Survival in Non-Liver-Transplant Patients with Liver Cirrhosis: A Systematic Review of the Literature

“…Its advantages are that the occluded vessels can be easily recanalized by endovascular techniques, and the patency of vessels can be effectively maintained by an accelerated blood flow through the main portal vein and shunt. However, its primary treatment goal remains to resolve the portal hypertension-related complications [ 39 ] because no controlled trials are available to confirm the benefits of TIPS versus anticoagulation for recanalizing the thrombosed portal vein [ 40 ]. Despite that, our systematic review showed that the survival of cirrhotic patients who were treated with TIPS or surgical shunts was not influenced by the presence of a preexistent PVT.…”

Portal Vein Thrombosis in Patients with Cirrhosis—Etiology, Diagnosis, and Management

“…Poor hepatic function (MELD >18) and presence of encephalopathy limit use in all patients. We await the results from a prospective randomized control trial conducted in China with great anticipation [69].…”