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Rifaximin in Patients With Gastroesophageal Variceal Bleeding (RFXM)

Fudan University logo

Fudan University

Status

Completed

Conditions

Cirrhosis
Gastrointestinal Hemorrhage
Esophageal and Gastric Varices

Treatments

Drug: Rifaximin

Study type

Interventional

Funder types

Other

Identifiers

NCT02991612
ZS-CSY-RFXM

Details and patient eligibility

About

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

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Rifaximin Treatment Group
Experimental group
Description:
Rifaximin 400mg bid for 2 months,
Treatment:
Drug: Rifaximin
Control Group
No Intervention group
Description:
Receive routine endoscopic treatment without having rifaximin for 2 months

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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