Cirrhosis, Esophageal and Gastric Varices, Gastrointestinal Hemorrhage
Conditions
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.
Interventions
DRUGRifaximin
ALFA WASSERMANN S.p.A.
Sponsors
Lanzhou University Second Hospital
Beijing Ditan Hospital
Shandong Provincial Hospital
Renmin Hospital of Wuhan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
The First Affiliated Hospital of Anhui Medical University
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Serum endotoxin, | 8 weeks, and 6 months | — |
| coagulation function | 8 weeks, and 6 months | — |
| All clinical events | 6 months | All clinical events were defined as occurrence rebreeding, ascitic fluid infection, or death. |
| Glucose breath hydrogen test | 8 weeks, and 6 months | — |
| changes of intestinal flora | 8 weeks, and 6 months | — |
| inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta | 8 weeks, and 6 months | — |
Countries
China
Contacts
Primary ContactXiaoquan HUANG, M.D.
Backup ContactShiyao CHEN, M.D.
Outcome results
None listed