TIPS vs Endoscopic Therapy for Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis

Liver Cirrhosis Clinical Trial

Official title:

TIPS Versus Endoscopic Therapy for the Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02485184
• Other study ID #: PVT-TIPS2
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Air Force Military Medical University, China
• Contact: Guohong Han, MD
• Phone: 86-13991969930
• Email: 13991969930[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Cirrhosis
• Portal Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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.

Drug:
• Non-selective beta blockers
Non-selective beta blockers are the drugs for reducing the portal pressure.

Procedure:
• Endoscopic therapy
Endoscopic therapy includes the endoscopic variceal band ligation

Drug:
• Anticoagulation
Anticoagulation therapy includes heparin and warfarin.

Locations

Country	Name	City	State
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	the First Affiliated Hospital, Air Force Medical University	Xi'an	Shaanxi
China	Xi'an International Medical Center Hospital	Xi'an	Shaanxi

Sponsors (7)

Lead Sponsor	Collaborator
Air Force Military Medical University, China	First Affiliated Hospital of Xinjiang Medical University, Shandong Provincial Hospital, Southern Medical University, China, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Nanchang University, Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause rebleeding or all-cause death	Cumulative incidence of all-cause rebleeding or all-cause death	3 years
Secondary	Portal vein recanalization	Incidence of portal vein recanalization	3 years
Secondary	Other decompensations of portal hypertension	defined as ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome	3 years
Secondary	adverse events of treatment	Incidence of adverse events of treatment	3 years
Secondary	Quality of life	quality of life assessed by the SF-36 health survey	3 years
Secondary	Overall survival	Overall survival rate	3 years
Secondary	Hepatocellular Carcinoma	Incidence of Hepatocellular Carcinoma	3 years