Clinical trial NCT01370161: Early TIPS With Polytetrafluoroethylene (PTFE) Covered Stents for Acute Variceal Bleeding in Patients With Advanced Cirrhosis
Official title: Early Transjugular Intrahepatic Portosystemic Shunt With Polytetrafluoroethylene Covered Stents Versus Standard Medical Therapy for Acute Variceal Bleeding in Patients With Advanced Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decompensated Cirrhosis
Bleeding Varices
Keywords: transjugular intrahepatic portosystemic shunt
TIPS
variceal bleeding
liver cirrhosis
hepatitis B
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2011-06-09
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of survival without liver transplantation
timeFrame: 2 years
Secondary outcomes:
measure: Number of participants failed to control acute variceal bleeding within 5 days, 6 weeks and 1 year
timeFrame: 1 years
measure: Number of bleeding related death
timeFrame: 2 years
measure: Number of other portal hypertension related complications on follow-up (ascites, hepatorenal syndrome, hepatic encephalopathy)
timeFrame: 2 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
name: Guohong Han, PhD & MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Pagan JC, Caca K, Bureau C, Laleman W, Appenrodt B, Luca A, Abraldes JG, Nevens F, Vinel JP, Mossner 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.
citation: Lv Y, Yang Z, Liu L, Li K, He C, Wang Z, Bai W, Guo W, Yu T, Yuan X, Zhang H, Xie H, Yao L, Wang J, Li T, Wang Q, Chen H, Wang E, Xia D, Luo B, Li X, Yuan J, Han N, Zhu Y, Niu J, Cai H, Xia J, Yin Z, Wu K, Fan D, Han G; AVB-TIPS Study Group. Early TIPS with covered stents versus standard treatment for acute variceal bleeding in patients with advanced cirrhosis: a randomised controlled trial. Lancet Gastroenterol Hepatol. 2019 Aug;4(8):587-598. doi: 10.1016/S2468-1253(19)30090-1. Epub 2019 May 29.