Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding
EoR-GEVB
1 other identifier
interventional
308
1 country
1
Brief Summary
The purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 7, 2016
CompletedFirst Posted
Study publicly available on registry
November 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedNovember 16, 2016
November 1, 2016
11 months
November 7, 2016
November 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
All clinical events
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death.
8 weeks
Secondary Outcomes (6)
All clinical events
6 months
Serum endotoxin,
8 weeks, and 6 months
coagulation function
8 weeks, and 6 months
inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta
8 weeks, and 6 months
Glucose breath hydrogen test
8 weeks, and 6 months
- +1 more secondary outcomes
Study Arms (2)
Rifaximin Group
EXPERIMENTALRifaximin 400 mg bid for 2 month,
Control
NO INTERVENTIONRoutine endoscopic treatment without prophylactic use of antibiotics
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Zhongshan Hospitallead
- Lanzhou University Second Hospitalcollaborator
- Beijing Ditan Hospitalcollaborator
- Shandong Provincial Hospitalcollaborator
- Renmin Hospital of Wuhan Universitycollaborator
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- The First Affiliated Hospital of Anhui Medical Universitycollaborator
Study Sites (1)
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032, China
Related Publications (5)
Bass NM, Mullen KD, Sanyal A, Poordad F, Neff G, Leevy CB, Sigal S, Sheikh MY, Beavers K, Frederick T, Teperman L, Hillebrand D, Huang S, Merchant K, Shaw A, Bortey E, Forbes WP. Rifaximin treatment in hepatic encephalopathy. N Engl J Med. 2010 Mar 25;362(12):1071-81. doi: 10.1056/NEJMoa0907893.
PMID: 20335583BACKGROUNDGarcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases; Practice Parameters Committee of the American College of Gastroenterology. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. doi: 10.1002/hep.21907. No abstract available.
PMID: 17879356BACKGROUNDGasbarrini A, Corazza GR, Gasbarrini G, Montalto M, Di Stefano M, Basilisco G, Parodi A, Usai-Satta P, Vernia P, Anania C, Astegiano M, Barbara G, Benini L, Bonazzi P, Capurso G, Certo M, Colecchia A, Cuoco L, Di Sario A, Festi D, Lauritano C, Miceli E, Nardone G, Perri F, Portincasa P, Risicato R, Sorge M, Tursi A; 1st Rome H2-Breath Testing Consensus Conference Working Group. Methodology and indications of H2-breath testing in gastrointestinal diseases: the Rome Consensus Conference. Aliment Pharmacol Ther. 2009 Mar 30;29 Suppl 1:1-49. doi: 10.1111/j.1365-2036.2009.03951.x.
PMID: 19344474BACKGROUNDHwang JH, Shergill AK, Acosta RD, Chandrasekhara V, Chathadi KV, Decker GA, Early DS, Evans JA, Fanelli RD, Fisher DA, Foley KQ, Fonkalsrud L, Jue T, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Sharaf R, Cash BD; American Society for Gastrointestinal Endoscopy. The role of endoscopy in the management of variceal hemorrhage. Gastrointest Endosc. 2014 Aug;80(2):221-7. doi: 10.1016/j.gie.2013.07.023. No abstract available.
PMID: 25034836BACKGROUNDVlachogiannakos J, Viazis N, Vasianopoulou P, Vafiadis I, Karamanolis DG, Ladas SD. Long-term administration of rifaximin improves the prognosis of patients with decompensated alcoholic cirrhosis. J Gastroenterol Hepatol. 2013 Mar;28(3):450-5. doi: 10.1111/jgh.12070.
PMID: 23216382BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shiyao CHEN, M.D.
Zhongshan Hospital, Fudan University, Shanghai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 7, 2016
First Posted
November 16, 2016
Study Start
November 1, 2016
Primary Completion
October 1, 2017
Study Completion
April 1, 2018
Last Updated
November 16, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share