Clinical trial NCT02485184: TIPS vs Endoscopic Therapy for Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis
Official title: TIPS Versus Endoscopic Therapy for the Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Portal Vein Thrombosis
Liver Cirrhosis
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Shandong Provincial Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Southern Medical University, China
name: First Affiliated Hospital of Xinjiang Medical University
name: The First Affiliated Hospital of Nanchang University
First posted: 2015-06-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: portal vein thrombosis may be a negative prognostic marker of variceal bleeding in liver cirrhosis. Compared with conventional endoscopic and pharmacological therapy, transjugular intrahepatic portosystemic shunt may further improve the outcomes of portal vein thrombosis in liver cirrhosis with variceal bleeding.

Detailed description: Portal vein thrombosis may be a negative prognostic marker of variceal bleeding in liver cirrhosis. Compared with conventional endoscopic and pharmacological therapy, transjugular intrahepatic portosystemic shunt may further improve the outcomes of portal vein thrombosis in liver cirrhosis with variceal bleeding. However, the safety of transjugular intrahepatic portosystemic shunt remains uncertain in patients with portal vein thrombosis.

Eligibility criteria: Inclusion criteria

1. liver cirrhosis (histological or clinical);
2. Significant variceal bleeding \>5 days and ≤ 42 days
3. Successful treatment of the index bleed by means of vasoactive drugs and/or endoscopic treatment
4. Portal vein thrombosis occlusion\>=25% of the vessel lumen;
5. Presence of ascites
6. Child-Pugh score 8-12 at inclusion
7. Age 18 to 70 years

Exclusion criteria

1. Bleeding from isolated gastric or ectopic varices
2. Contraindications to non-selective beta blockers (chronic obstructive pulmonary disease, asthma, aortic stenosis, atrioventricular block, intermittent claudication, and psychosis)
3. Contraindications to TIPS : extensive potral vein thrombosis, fibrotic cord replacing original main portal vein; bilirubin\>3.5 mg/dL, plasma creatinine\>2.1 mg/dL, Child-Pugh score \>=13points
4. A history of significant heart failure (New York Heart Association class III and IV)
5. Overt hepatic encephalopathy,
6. Prehepatic portal hypertension
7. Malignancy (including hepatocellular carcinoma) or a concomitant disease with reduced life expectancy
8. Uncontrolled infection and sepsis
9. Previous treatment to prevent rebleeding with a portosystemic shunt,TIPS or with pharmacological therapy with non-selective beta blockers and endoscopic variceal ligation
10. Pregnancy or lactation

Primary outcomes:
measure: All-cause rebleeding or all-cause death
timeFrame: 3 years
Secondary outcomes:
measure: Portal vein recanalization
timeFrame: 3 years
measure: Other decompensations of portal hypertension
timeFrame: 3 years
measure: adverse events of treatment
timeFrame: 3 years
measure: Quality of life
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Hepatocellular Carcinoma
timeFrame: 3 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: the First Affiliated Hospital, Air Force Medical University
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an International Medical Center Hospital
state: Shaanxi
city: Guangzhou
country: China
facility: Nanfang Hospital Affiliated to Southern Medical Univers
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
city: Jinan
country: China
facility: Provincial Hospital Affiliated to Shandong University
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Affiliated Drum Tower Hospital of Nanjing University Medical School
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
Study officials:
affiliation: Xi'an International Medical Center Hospital
name: Guohong Han, MD
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: Lv Y, He C, Wang Z, Guo W, Wang J, Bai W, Zhang L, Wang Q, Liu H, Luo B, Niu J, Li K, Tie J, Yin Z, Fan D, Han G. Association of Nonmalignant Portal Vein Thrombosis and Outcomes after Transjugular Intrahepatic Portosystemic Shunt in Patients with Cirrhosis. Radiology. 2017 Dec;285(3):999-1010. doi: 10.1148/radiol.2017162266. Epub 2017 Jul 5.