Trial | NCT02964195  Report issue

Title

Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding
Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Hemorrhage: A Multi-center Randomized Controlled Clinical Trial

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    rifaximin ...

  • Study Participants

    308
The purpose of the study is to evaluate the 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.

The purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.
Study Started
Nov 30
2016
Primary Completion
Oct 31
2017
Anticipated
Study Completion
Apr 30
2018
Anticipated
Last Update
Nov 16
2016
Estimate

Drug Rifaximin

ALFA WASSERMANN S.p.A.

  • Other names: XIFAXAN

Rifaximin Group Experimental

Rifaximin 400 mg bid for 2 month,

Control No Intervention

Routine endoscopic treatment without prophylactic use of antibiotics

Criteria 

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
No Results Posted