Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding (EoR-GEVB)

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

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

Study Overview

• Status: Unknown
• Conditions: Cirrhosis; Esophageal and Gastric Varices; Gastrointestinal Hemorrhage
• Intervention / Treatment: Drug: Rifaximin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 308
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoquan HUANG, M.D.; Phone Number: 18801733835; Email: huangxiaoquan1010@aliyun.com
• Study Contact Backup: Name: Shiyao CHEN, M.D.; Phone Number: 13601767310; Email: chen.shiyao@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • 180 Fenglin Road
      • Principal Investigator: Shiyao Chen, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rifaximin Group; Rifaximin 400 mg bid for 2 month,	Drug: Rifaximin; ALFA WASSERMANN S.p.A.; Other Names: XIFAXAN
No Intervention: Control; Routine endoscopic treatment without prophylactic use of antibiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All clinical events	All clinical events were defined as occurrence rebreeding, ascitic fluid infection, or death.	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
changes of intestinal flora		8 weeks, and 6 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: The First Affiliated Hospital of Anhui Medical University; Beijing Ditan Hospital; Shandong Provincial Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Renmin Hospital of Wuhan University; Second Hospital of Lanzhou University

Publications and helpful links

General Publications

• Vlachogiannakos 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.
• Garcia-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. Erratum In: Hepatology. 2007 Dec;46(6):2052.
• 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.
• Gasbarrini 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. Erratum In: Aliment Pharmacol Ther. 2010 Jan;31(1):166. Satta PU [corrected to Usai-Satta P].
• Hwang 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimate): November 16, 2016

Study Record Updates

• Last Update Posted (Estimate): November 16, 2016
• Last Update Submitted That Met QC Criteria: November 10, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Hemorrhage; Esophageal and Gastric Varices; Gastrointestinal Hemorrhage; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin
• Other Study ID Numbers: CSY-Rifaximin-HXQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No