Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding

Not Applicable

• Conditions: Esophageal and Gastric Varices; Cirrhosis; Gastrointestinal Hemorrhage
• Interventions: Drug: Rifaximin

• Registration Number: NCT02964195
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-10
• Last Update Submitted: 2016-11-10
• Study First Posted: 2016-11-16
• Last Update Posted: 2016-11-16
• Primary Completion: 2017-10
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 308

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rifaximin Group	Rifaximin	Rifaximin 400 mg bid for 2 month,

Primary Outcome Measures

Name	Time	Method
All clinical events	8 weeks	All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death.

Secondary Outcome Measures

Name	Time	Method
Glucose breath hydrogen test	8 weeks, and 6 months
coagulation function	8 weeks, and 6 months
inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta	8 weeks, and 6 months
All clinical events	6 months	All clinical events were defined as occurrence rebreeding, ascitic fluid infection, or death.
changes of intestinal flora	8 weeks, and 6 months
Serum endotoxin,	8 weeks, and 6 months

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, Shanghai, China