TIPS vs Endoscopic Therapy for Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis
NCT ID: NCT02485184
Last Updated: 2022-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2017-07-09
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TIPS group
Transjugular intrahepatic portosystemic shunt
Transjugular intrahepatic portosystemic shunt
Transjugular intrahepatic portosystemic shunt refers to an interventional radiological procedure by placing a stent between portal vein and hepatic vein. No specific device was used in the Interventional field.
ET & drugs groups
1. Endoscopic therapy.
2. Non-selective beta blockers.
3. Anticoagulation therapy.
Non-selective beta blockers
Non-selective beta blockers are the drugs for reducing the portal pressure.
Endoscopic therapy
Endoscopic therapy includes the endoscopic variceal band ligation
Anticoagulation
Anticoagulation therapy includes heparin and warfarin.
Interventions
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Transjugular intrahepatic portosystemic shunt
Transjugular intrahepatic portosystemic shunt refers to an interventional radiological procedure by placing a stent between portal vein and hepatic vein. No specific device was used in the Interventional field.
Non-selective beta blockers
Non-selective beta blockers are the drugs for reducing the portal pressure.
Endoscopic therapy
Endoscopic therapy includes the endoscopic variceal band ligation
Anticoagulation
Anticoagulation therapy includes heparin and warfarin.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Shandong Provincial Hospital
OTHER_GOV
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Southern Medical University, China
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Air Force Military Medical University, China
OTHER
Responsible Party
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Guohong Han
Professor
Principal Investigators
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Guohong Han, MD
Role: PRINCIPAL_INVESTIGATOR
Xi'an International Medical Center Hospital
Locations
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the First Affiliated Hospital, Air Force Medical University
Xi'an, Shaanxi, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China
Nanfang Hospital Affiliated to Southern Medical Univers
Guangzhou, , China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, , China
Provincial Hospital Affiliated to Shandong University
Jinan, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, , China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, , China
Countries
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Central Contacts
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Facility Contacts
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Jianbo Zhao, MD
Role: primary
Ming-an Li, MD
Role: primary
Chunqing Zhang, MD
Role: primary
Xuan Zhu, MD
Role: primary
Yuzheng Zhuge, MD
Role: primary
Weixin Ren, MD
Role: primary
References
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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.
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.
Other Identifiers
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PVT-TIPS2
Identifier Type: -
Identifier Source: org_study_id
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