Rifaximin in Patients With Gastroesophageal Variceal Bleeding

Not Applicable

Completed

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

• Registration Number: NCT02991612
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

Study Timeline

• Study Start: 2016-11-25
• Study First Submitted: 2016-12-10
• Study First Submitted QC: 2016-12-10
• Study First Posted: 2016-12-13
• Primary Completion: 2017-12-22
• Study Completion: 2018-02-28
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rifaximin Treatment Group	Rifaximin	Rifaximin 400mg bid for 2 months,

Primary Outcome Measures

Name	Time	Method
Incidence of all clinical adverse events	8 weeks	The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks

Secondary Outcome Measures

Name	Time	Method
Changes of portal vein thrombosis	2 months	complete or partial recanalization of thrombosis
Changes of intestinal flora	2 months	Metagenomics sequencing
The changes of serum level of cytokines	8 weeks	Cytokines including TNF-α, IL-1β, IL-2R, IL-6 and IL-10, etc

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, Shanghai, China