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

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Decompensated Cirrhosis; Bleeding Varices

Treatments: Drug: Medical treatment; Procedure: TIPS treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01370161

FMMU-XHDD 002 (Registry Identifier)

XHDD 002

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

TIPS treatment

Experimental group

Description:

Initial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.TIPS will be performed as soon as possible once the patients are enrolled in the study, always within the first 72 hours after the diagnostic endoscopy (preferably in the first 24 hours).Vasoactive drugs will be continued until the TIPS is performed and antibiotics will be continued for 5-7 days.

Treatment:

Procedure: TIPS treatment

Medical treatment

Active Comparator group

Description:

Initial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.Patients will be treated with non-selective beta-blockers (propranolol)on day 5. In case of contraindications or intolerance to beta-blockers, patients will not receive pharmacological treatment (beta-blockers) and the only treatment to prevent rebleeding will be endoscopic band ligation.

Treatment:

Drug: Medical treatment