Clinical trial NCT01326949: Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis
Official title: Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Treatment Combined With Propranolol for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decompensated Cirrhosis
Portal Vein Thrombosis
Bleeding Varices
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2011-03-31
Enrollment: 52
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: TREATMENT

Brief summary: Portal vein thrombosis (PVT) refers to an obstruction in the trunk of the portal vein. It can extend downstream to the portal branches, or upstream to the splenic and/or the mesenteric veins. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients. Recent studies demonstrate that the presence of PVT is not only an independent predictor of failure to control active variceal bleeding and prevent variceal rebleeding, but also significantly associated with increased mortality in patients with liver cirrhosis.

However, in recent American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus, no treatment strategies in cirrhotic patients with PVT was clearly recommended due to the absence of randomized controlled trials.

Detailed description: Usually, cirrhotic patients with PVT are submitted to variceal rebleeding prophylaxis with endoscopic band ligation combined with non-selective beta-blockers and, when necessary, the anticoagulation is started after the varices eradication.

TIPS is just regarded as the second-line therapy for the secondary prophylaxis of variceal bleeding in cirrhotic patients. However, this indication might be changed in the setting of PVT. Indeed, the risk to benefit ratio of TIPS in cirrhotic patients with PVT for the prevention of recurrent variceal bleeding has never been evaluated.

The aim of this study is to compare the efficacy and safety of TIPS and endoscopic band ligation + propranolol in decompensated cirrhosis patients with PVT and a history of variceal bleeding in the past 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Liver cirrhosis
* Portal vein thrombosis (degree of vessel obstruction \> 50%)
* History of variceal hemorrhage in the past 6 weeks (recent variceal bleeding has been controlled for at least 120 hours)

Exclusion Criteria:

* Uncontrolled active variceal bleeding
* Fibrotic cord of the portal vein
* Prior history of TIPS placement or shunt surgery or endoscopic ban ligation +NSBB
* Concomitant renal insufficiency
* Severe cardiopulmonary diseases
* Uncontrolled systemic infection or sepsis
* Malignancy or other serious medical illness which may reduce the life expectancy
* Contraindications for propranolol, such as asthma, insulin-dependent diabetes (with episodes of hypoglycemia), and peripheral vascular disease
* Contraindications for heparin or warfarin
* Contraindications for TIPS

Primary outcomes:
measure: Number of participants with variceal rebleeding
timeFrame: 4 years
Secondary outcomes:
measure: Number of death
timeFrame: 4 years
measure: Number of participants achieving portal vein recanalization
timeFrame: 4 years
measure: Changes of degree of PVT in patients without portal vein recanalization
timeFrame: 4 years
measure: Number of complications
timeFrame: 4 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
name: Guohong Han
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han G, Qi X, He C, Yin Z, Wang J, Xia J, Yang Z, Bai M, Meng X, Niu J, Wu K, Fan D. Transjugular intrahepatic portosystemic shunt for portal vein thrombosis with symptomatic portal hypertension in liver cirrhosis. J Hepatol. 2011 Jan;54(1):78-88. doi: 10.1016/j.jhep.2010.06.029. Epub 2010 Aug 27.
citation: Simonetti RG, Perricone G, Robbins HL, Battula NR, Weickert MO, Sutton R, Khan S. Portosystemic shunts versus endoscopic intervention with or without medical treatment for prevention of rebleeding in people with cirrhosis. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD000553. doi: 10.1002/14651858.CD000553.pub3.
citation: Lv Y, Qi X, He C, Wang Z, Yin Z, Niu J, Guo W, Bai W, Zhang H, Xie H, Yao L, Wang J, Li T, Wang Q, Chen H, Liu H, Wang E, Xia D, Luo B, Li X, Yuan J, Han N, Zhu Y, Xia J, Cai H, Yang Z, Wu K, Fan D, Han G; PVT-TIPS Study Group.. Covered TIPS versus endoscopic band ligation plus propranolol for the prevention of variceal rebleeding in cirrhotic patients with portal vein thrombosis: a randomised controlled trial. Gut. 2018 Dec;67(12):2156-2168. doi: 10.1136/gutjnl-2017-314634. Epub 2017 Sep 28.
citation: Qi X, He C, Yin Z, Wang Z, Zhang H, Yao L, Wang J, Xia J, Cai H, Yang Z, Bai M, Guo W, Niu J, Wu K, Fan D, Han G; PVT-TIPS Study Group. Transjugular intrahepatic portosystemic shunt for the prevention of variceal rebleeding in cirrhotic patients with portal vein thrombosis: study protocol for a randomised controlled trial. BMJ Open. 2013 Jul 11;3(7):e003370. doi: 10.1136/bmjopen-2013-003370. Print 2013.