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NCT01370161·Not applicable·INTERVENTIONAL

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

TerlipressinOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

132

Locations

1

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

PROCEDURE

TIPS treatment

1. 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. 2. 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. 3. 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.

Timeline

From registration to results.

  1. First posted

    Jun 9, 2011

  2. Study start

    Jul 2011

  3. Primary completion

    Sep 30, 2018

  4. Study completion

    Sep 30, 2018

  5. Results posted

    Not reported

  6. Registry updated

    Jan 17, 2019

Outcomes

What the study measures.

Primary outcomes

Number of survival without liver transplantation

Time frame · 2 years

Secondary outcomes

Number of participants failed to control acute variceal bleeding within 5 days, 6 weeks and 1 year

Time frame · 1 years

Number of bleeding related death

Time frame · 2 years

Number of other portal hypertension related complications on follow-up (ascites, hepatorenal syndrome, hepatic encephalopathy)

Time frame · 2 years

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, China

Publications

Results and literature.

PMID 20573925 ↗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.PMID 31153882 ↗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.

Primary links

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