Rifaximin in Patients With Gastroesophageal Variceal Bleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-25

Study Completion Date

2018-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cirrhosis Esophageal and Gastric Varices Gastrointestinal Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rifaximin Treatment Group

Rifaximin 400mg bid for 2 months,

Group Type EXPERIMENTAL

Rifaximin

Intervention Type DRUG

Patients receive Rifaximin 400mg bid for 2 months

Control Group

Receive routine endoscopic treatment without having rifaximin for 2 months

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rifaximin

Patients receive Rifaximin 400mg bid for 2 months

Intervention Type DRUG

Other Intervention Names

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XIFAXAN

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No