Rifaximin in Patients With Gastroesophageal Variceal Bleeding

Shanghai Zhongshan Hospital80 enrolled

Overview

The purpose of the study is to evaluate the safety and 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cirrhosis Esophageal and Gastric Varices Gastrointestinal Hemorrhage

Interventions

RifaximinDRUG

Patients receive Rifaximin 400mg bid for 2 months

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 tumors (not exclude patients with hepatocellular carcinoma who don't need treatment at the moment); * Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.) * Massive ascites or combined with other high-risk factors that require prophylaxis use of antibiotics. * Acute variceal bleeding within 5 days. * Refuse to participate

Locations (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Incidence of all clinical adverse events

The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks

Time frame: 8 weeks

Secondary Outcomes

Changes of portal vein thrombosis

complete or partial recanalization of thrombosis

Time frame: 2 months

Changes of intestinal flora

Metagenomics sequencing

Time frame: 2 months

The changes of serum level of cytokines

Cytokines including TNF-α, IL-1β, IL-2R, IL-6 and IL-10, etc

Time frame: 8 weeks

Data from ClinicalTrials.gov

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