Early TIPS With Polytetrafluoroethylene (PTFE) Covered Stents for Acute Variceal Bleeding in Patients With Advanced Cirrhosis

Decompensated Cirrhosis Clinical Trial

Official title:

Early Transjugular Intrahepatic Portosystemic Shunt With Polytetrafluoroethylene Covered Stents Versus Standard Medical Therapy for Acute Variceal Bleeding in Patients With Advanced Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370161
• Other study ID #: XHDD 002
• Secondary ID: FMMU-XHDD 002
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: September 30, 2018

Study information

• Verified date: January 2019
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether early use of transjugular intrahepatic portosystemic shunt (TIPS) with Polytetrafluoroethylene (PTFE) covered stents is able to prolong the survival in patients with advanced cirrhosis and acute variceal bleeding.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• History of cirrhosis (clinical or by liver biopsy)

• Admission due to acute bleeding from oesophageal or gastric (GOV1 or GOV2) varices

• Child-Pugh Class C (Child-Pugh score less than or equal to 13) or Child-Pugh class B

• Signed written informed consent

Exclusion Criteria:

• Patients not fulfilling inclusion criteria

• Pregnancy or breast-feeding

• Confirmed hepatocellular carcinoma

• Creatinine greater than 3 mg/dl

• Terminal hepatic failure (Child-Pugh score greater than 13)

• Previous treatment with TIPS or combined pharmacological and endoscopic treatment to prevent rebleeding

• Fundal or ectopic gastric variceal bleeding (IGV1 or IGV2)

• Complete portal vein thrombosis or portal cavernoma

• Congestive heart failure New York Heart Association (NYHA) greater than III or medical history of pulmonary hypertension

• Spontaneous recurrent hepatic encephalopathy

Related Conditions & MeSH terms

• Bleeding Varices
• Decompensated Cirrhosis
• Fibrosis
• Hemorrhage
• Liver Cirrhosis

Intervention

Procedure:
• TIPS treatment
A 8 mm Fluency stent will be used. The aim will be to reduce the portal pressure gradient (PPG) below to 12 mm Hg or 25-75% of baseline. Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of large portosystemic collaterals feeding the varices. After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted.

Drug:
• Medical treatment
Patients will receive vasoactive drugs up to 5 days; then a non-selective beta-blocker (propranolol) will be started with an initial dose of 40 mg, the dose of propranolol will be increased/decreased step by step to achieve a baseline heart rate of 55 bpm, or 25% reduction of basal heart rate or up to the maximum tolerated dose of propranolol. The second elective session of endoscopic band ligation will be performed within the first 7-14 days after the initial endoscopic treatment. The following sessions will be performed at 14 +/- 3 days intervals until variceal eradication. Once eradication is achieved, endoscopic monitoring will be performed every 6 months. If varices reappear, new band ligation will be performed.

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)

García-Pagán JC, Caca K, Bureau C, Laleman W, Appenrodt B, Luca A, Abraldes JG, Nevens F, Vinel JP, Mössner J, Bosch J; Early TIPS (Transjugular Intrahepatic Portosystemic Shunt) Cooperative Study Group. Early use of TIPS in patients with cirrhosis and variceal bleeding. N Engl J Med. 2010 Jun 24;362(25):2370-9. doi: 10.1056/NEJMoa0910102. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of survival without liver transplantation		2 years
Secondary	Number of participants failed to control acute variceal bleeding within 5 days, 6 weeks and 1 year		1 years
Secondary	Number of bleeding related death		2 years
Secondary	Number of other portal hypertension related complications on follow-up (ascites, hepatorenal syndrome, hepatic encephalopathy)		2 years