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

Primary Purpose

Cirrhosis, Esophageal and Gastric Varices, Gastrointestinal Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rifaximin
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 180 Fenglin RoadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rifaximin Group

Control

Arm Description

Rifaximin 400 mg bid for 2 month,

Routine endoscopic treatment without prophylactic use of antibiotics

Outcomes

Primary Outcome Measures

All clinical events
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death.

Secondary Outcome Measures

All clinical events
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, or death.
Serum endotoxin,
coagulation function
inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta
Glucose breath hydrogen test
changes of intestinal flora

Full Information

First Posted
November 7, 2016
Last Updated
November 10, 2016
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Second Hospital of Lanzhou University, 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
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1. Study Identification

Unique Protocol Identification Number
NCT02964195
Brief Title
Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding
Acronym
EoR-GEVB
Official Title
Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Hemorrhage: A Multi-center Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Second Hospital of Lanzhou University, 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Esophageal and Gastric Varices, Gastrointestinal Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
308 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin Group
Arm Type
Experimental
Arm Description
Rifaximin 400 mg bid for 2 month,
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine endoscopic treatment without prophylactic use of antibiotics
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
XIFAXAN
Intervention Description
ALFA WASSERMANN S.p.A.
Primary Outcome Measure Information:
Title
All clinical events
Description
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
All clinical events
Description
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, or death.
Time Frame
6 months
Title
Serum endotoxin,
Time Frame
8 weeks, and 6 months
Title
coagulation function
Time Frame
8 weeks, and 6 months
Title
inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta
Time Frame
8 weeks, and 6 months
Title
Glucose breath hydrogen test
Time Frame
8 weeks, and 6 months
Title
changes of intestinal flora
Time Frame
8 weeks, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoquan HUANG, M.D.
Phone
18801733835
Email
huangxiaoquan1010@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyao CHEN, M.D.
Phone
13601767310
Email
chen.shiyao@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyao CHEN, M.D.
Organizational Affiliation
Zhongshan Hospital, Fudan University, Shanghai
Official's Role
Principal Investigator
Facility Information:
Facility Name
180 Fenglin Road
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoquan HUANG, M.D.
Phone
+86-18801733835
Email
huangxiaoquan1010@aliyun.com
First Name & Middle Initial & Last Name & Degree
Shiyao Chen, Professor

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20335583
Citation
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.
Results Reference
background
PubMed Identifier
17879356
Citation
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.
Results Reference
background
PubMed Identifier
19344474
Citation
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].
Results Reference
background
PubMed Identifier
25034836
Citation
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.
Results Reference
background
PubMed Identifier
23216382
Citation
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.
Results Reference
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Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding

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