Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding

Shanghai Zhongshan Hospital308 enrolled

Overview

The purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.

Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection. However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences. The purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

308

Conditions

Cirrhosis Esophageal and Gastric Varices Gastrointestinal Hemorrhage

Interventions

RifaximinDRUG

ALFA WASSERMANN S.p.A.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 y.o. ≤age≤75 y.o.; * Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric N-butyl-cyanoacrylate injection). Exclusion Criteria: * age \<18 y.o. or age \> 75 y.o.; * Never had the variceal bleeding episode before; * Do not have endoscopic treatment; * combined with other malignant tumor (not exclude patients with hepatocellular carcinoma who don't not need treatment at the moment); * Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.) * Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics. * Acute variceal bleeding within 5 days. * Use of other antibiotics in the past 2 weeks; * Refuse to participate

Locations (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

All clinical events

All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death.

Time frame: 8 weeks

Secondary Outcomes

All clinical events

All clinical events were defined as occurrence rebreeding, ascitic fluid infection, or death.

Time frame: 6 months

Serum endotoxin,