TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding

Portal Hypertension Clinical Trial

— T8/10SVB  

Official title:

The Effect of TIPS With 8- or 10-mm Covered Stent for Preventing Variceal Rebleeding in Cirrhotic Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410591
• Other study ID #: T8/10CSVB
• Secondary ID: FMMU-XHDD 003
• Status: Completed
• Phase: N/A
• First received: August 4, 2011
• Last updated: January 23, 2016
• Start date: July 2012
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether transjugular intrahepatic portosystemic shunt (TIPS) with 10-mm covered stent is associated with lower shunt dysfunction in comparing TIPS with 8-mm covered stent in cirrhotic patients with at least one episode of variceal bleeding.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Cirrhotic patients with at least one episode of variceal bleeding

• No active bleeding within 5 days before TIPS

• Child-Pugh score =13

• Signed written informed consent

Exclusion Criteria:

• An age <18 years or >75 years

• With TIPS contraindications

• Past or present history of hepatic encephalopathy

• Pregnancy or breast-feeding

• Hepatic carcinoma and/or other malignancy diseases

• Sepsis

• Spontaneous bacterial peritonitis

• Uncontrollable hypertension

• Serious cardiac or pulmonary dysfunction

• Renal failure

• Portal vein thrombosis

• History of organ transplantation

• History of HIV (human immunodeficiency viruses) infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding Varices
• Decompensated Cirrhosis
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Device:
• 8-mm covered stent group
Creating a shunt between hepatic vein and portal vein with a 8-mm covered stent by TIPS procedure.
• 10-mm covered stent group
Creating a shunt between hepatic vein and portal vein with a 10-mm covered stent by TIPS procedure.

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases, Fourth Military Medical University	Xi`an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Riggio O, Ridola L, Angeloni S, Cerini F, Pasquale C, Attili AF, Fanelli F, Merli M, Salvatori FM. Clinical efficacy of transjugular intrahepatic portosystemic shunt created with covered stents with different diameters: results of a randomized controlled trial. J Hepatol. 2010 Aug;53(2):267-72. doi: 10.1016/j.jhep.2010.02.033. Epub 2010 Apr 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of shunt dysfunction.		2 years	No
Secondary	Incidence of variceal rebleeding		2 years	Yes
Secondary	Incidence of hepatic encephalopathy		2 years	Yes
Secondary	Survival		2 years	Yes
Secondary	Incidence of hepatic myelopathy		2 years	Yes