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

Not Applicable

Completed

• Conditions: Bleeding Varices; Decompensated Cirrhosis
• Interventions: Procedure: TIPS treatment; Drug: Medical treatment

• Registration Number: NCT01370161
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-09
• Study Start: 2011-07
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIPS treatment	TIPS treatment	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.
Medical treatment	Medical treatment	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.

Primary Outcome Measures

Name	Time	Method
Number of survival without liver transplantation	2 years

Secondary Outcome Measures

Name	Time	Method
Number of participants failed to control acute variceal bleeding within 5 days, 6 weeks and 1 year	1 years
Number of bleeding related death	2 years
Number of other portal hypertension related complications on follow-up (ascites, hepatorenal syndrome, hepatic encephalopathy)	2 years

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China