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8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding

Information source: West China Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Portal Hypertension

Intervention: 8mm-TIPS (Procedure); Endoscopic variceal ligation (Procedure); Propranolol (Drug); 8mm ePTFE-covered stent (Device)

Phase: N/A

Status: Recruiting

Sponsored by: West China Hospital

Summary

The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.

Clinical Details

Official title: Randomised Trial of 8mm Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Propranolol for Prevention of Variceal Rebleeding

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Variceal rebleeding rate

Secondary outcome:

Hepatic encephalopathy rate

Number of participants with improving or worsening hepatic function

TIPS dysfunction rate

The incidence of complications

Number of participants with improving or worsening quality of life

Mortality rate

Detailed description: For the prevention of recurrent esophageal variceal bleeding, previous clinical studies and meta-analysis show that patients treated with transjugular intrahepatic portosystemic shunt (TIPS) have lower rebleeding rates compared with endoscopic therapy. However, TIPS is associated with higher rates of portosystemic encephalopathy and does not show survival benefit. TIPS with a small-diameter may achieve sufficient portal decompression and reduce the incidence of hepatic encephalopathy. The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm ePTFE-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Cirrhosis 2. Patients who had bled from esophageal varices (≥5days and ≤28days) 3. Child-Pugh B or Child-Pugh C≤13 Exclusion Criteria: 1. THE presence of gastric varices 2. Non-cirrhotic portal hypertension 3. Portal vein thrombosis 4. The history of hepatic encephalopathy 5. Total bilirubin ≥51. 3 umol/L 6. Previous treatment of TIPS or surgery 7. Proven malignancy including hepatocellular carcinoma 8. Contraindications to TIPS、EVL or propranolol 9. End-stage renal disease under renal replacement therapy; 10. Cardiorespiratory failure 11. Pregnancy or patients not giving informed consent for endoscopic procedures

Locations and Contacts

West China Hospital, Chengdu, Sichuan 610041, China; Recruiting
Xuefeng Luo, MD, Phone: 862885422389
Additional Information

Starting date: June 2015
Last updated: July 30, 2015

Page last updated: August 23, 2015

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