Clinical trial NCT01410591: TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding
Official title: The Effect of TIPS With 8- or 10-mm Covered Stent for Preventing Variceal Rebleeding in Cirrhotic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decompensated Cirrhosis
Portal Hypertension
Bleeding Varices
Keywords: transjugular intrahepatic portosystemic shunt
TIPS
liver cirrhosis
variceal bleeding
8- or 10-mm covered stent
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2011-08-05
Enrollment: 127
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of shunt dysfunction.
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of variceal rebleeding
timeFrame: 2 years
measure: Incidence of hepatic encephalopathy
timeFrame: 2 years
measure: Survival
timeFrame: 2 years
measure: Incidence of hepatic myelopathy
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: 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.
citation: Wang Q, Lv Y, Bai M, Wang Z, Liu H, He C, Niu J, Guo W, Luo B, Yin Z, Bai W, Chen H, Wang E, Xia D, Li X, Yuan J, Han N, Cai H, Li T, Xie H, Xia J, Wang J, Zhang H, Wu K, Fan D, Han G. Eight millimetre covered TIPS does not compromise shunt function but reduces hepatic encephalopathy in preventing variceal rebleeding. J Hepatol. 2017 Sep;67(3):508-516. doi: 10.1016/j.jhep.2017.05.006. Epub 2017 May 12.