Cirrhosis Clinical Trial
— RFXMOfficial title:
Efficacy of Rafiximin in Patients With Cirrhotic Gastroesophageal Variceal Hemorrhage: A Single-center Pilot Study
Verified date | May 2018 |
Source | Shanghai Zhongshan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.
Status | Completed |
Enrollment | 80 |
Est. completion date | February 28, 2018 |
Est. primary completion date | December 22, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | 180 Fenglin Road | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of all clinical adverse events | The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks | 8 weeks | |
Secondary | Changes of portal vein thrombosis | complete or partial recanalization of thrombosis | 2 months | |
Secondary | Changes of intestinal flora | Metagenomics sequencing | 2 months | |
Secondary | The changes of serum level of cytokines | Cytokines including TNF-a, IL-1ß, IL-2R, IL-6 and IL-10, etc | 8 weeks |
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