TIPS vs Endoscopic Therapy for Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: TIPS group Transjugular intrahepatic portosystemic shunt |
Procedure: 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.
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| Active Comparator: ET & drugs groups Endoscopic therapy. Non-selective beta blockers. Anticoagulation therapy. |
Drug: Non-selective beta blockers
Non-selective beta blockers are the drugs for reducing the portal pressure.
Other Names:
Procedure: Endoscopic therapy
Endoscopic therapy includes the endoscopic variceal band ligation
Drug: Anticoagulation
Anticoagulation therapy includes heparin and warfarin.
Other Names:
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Outcome Measures
Primary Outcome Measures
- All-cause rebleeding or all-cause death [3 years]
Cumulative incidence of all-cause rebleeding or all-cause death
Secondary Outcome Measures
- Portal vein recanalization [3 years]
Incidence of portal vein recanalization
- Other decompensations of portal hypertension [3 years]
defined as ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome
- adverse events of treatment [3 years]
Incidence of adverse events of treatment
- Quality of life [3 years]
quality of life assessed by the SF-36 health survey
- Overall survival [3 years]
Overall survival rate
- Hepatocellular Carcinoma [3 years]
Incidence of Hepatocellular Carcinoma
Eligibility Criteria
Criteria
Inclusion criteria
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liver cirrhosis (histological or clinical);
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Significant variceal bleeding >5 days and ≤ 42 days
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Successful treatment of the index bleed by means of vasoactive drugs and/or endoscopic treatment
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Portal vein thrombosis occlusion>=25% of the vessel lumen;
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Presence of ascites
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Child-Pugh score 8-12 at inclusion
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Age 18 to 70 years
Exclusion criteria
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Bleeding from isolated gastric or ectopic varices
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Contraindications to non-selective beta blockers (chronic obstructive pulmonary disease, asthma, aortic stenosis, atrioventricular block, intermittent claudication, and psychosis)
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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
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A history of significant heart failure (New York Heart Association class III and IV)
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Overt hepatic encephalopathy,
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Prehepatic portal hypertension
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Malignancy (including hepatocellular carcinoma) or a concomitant disease with reduced life expectancy
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Uncontrolled infection and sepsis
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Previous treatment to prevent rebleeding with a portosystemic shunt,TIPS or with pharmacological therapy with non-selective beta blockers and endoscopic variceal ligation
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Pregnancy or lactation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xijing Hospital of digestive disease, Fourth Military Medical University | Xi'an | Shaanxi | China | 710032 |
| 2 | Nanfang Hospital Affiliated to Southern Medical Univers | Guangzhou | China | ||
| 3 | The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | China | ||
| 4 | Provincial Hospital Affiliated to Shandong University | Jinan | China | ||
| 5 | The First Affiliated Hospital of Nanchang University | Nanchang | China | ||
| 6 | Affiliated Drum Tower Hospital of Nanjing University Medical School | Nanjing | China | ||
| 7 | The First Affiliated Hospital of Xinjiang Medical University | Urumchi | China |
Sponsors and Collaborators
- Air Force Military Medical University, China
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Shandong Provincial Hospital
- Third Affiliated Hospital, Sun Yat-Sen University
- Southern Medical University, China
- First Affiliated Hospital of Xinjiang Medical University
- The First Affiliated Hospital of Nanchang University
Investigators
- Principal Investigator: Guohong Han, MD, Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- PVT-TIPS2