Antibiotic Prophylaxis in Patients Undergoing GVO (ABX-GV)
Primary Purpose
Gastric Varix, Sepsis, Liver Cirrhoses
Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Ertapenem
Sponsored by
About this trial
This is an interventional prevention trial for Gastric Varix focused on measuring Gastric variceal rebleeding, Sepsis, cyanoacrylate injection
Eligibility Criteria
Inclusion Criteria:
- Patients with live cirrhosis and/or hepatoma
- Aged 20 to 85, who had endoscopy-treatment EV(-)GV(+)or EV<GV
Exclusion Criteria:
- Had a terminal illness of any major organ system,such as heart failure, kindey failure,COPD
- Patients recieve antibiotics recently.
- Patients suspected infection.
Sites / Locations
- Veteran General Hospital-TaipeiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Antibiotic
Control
Arm Description
Participate will be acepted ertapenem(1g) iv before endoscopic cyanoacrylate injection obliteration
Participate will not be acepted ertapenem(1g) iv before endoscopic cyanoacrylate injection obliteration
Outcomes
Primary Outcome Measures
Prevetion of sepsis
If Antibiotic Prophylaxis can reduce sepsis in Patients Undergoing GVO
Secondary Outcome Measures
Rebleeding rate
If Antibiotic Prophylaxis can reduce GV rebleeding rate
Pevention of Refractory bacterial infection
If Antibiotic Prophylaxis can reduce infection rate in Patients Undergoing GVO
Mortality
If Antibiotic Prophylaxis can decrease mortality in Patients Undergoing GVO
Full Information
NCT ID
NCT04140578
First Posted
August 29, 2019
Last Updated
October 24, 2019
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04140578
Brief Title
Antibiotic Prophylaxis in Patients Undergoing GVO
Acronym
ABX-GV
Official Title
Antibiotic Prophylaxis in Patients Undergoing Endoscopic Injection of Cyanoacrylate for Primary and Secondary Prevention of Gastric Variceal Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Recruiting
Study Start Date
January 28, 2017 (Actual)
Primary Completion Date
December 31, 2030 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
We design a randomized trial to clarify the necessity of antibiotic prophylaxis for the patients chronic liver disease with gastric varices treated by elective GVO.
Detailed Description
Gastric varices is not uncommon is patients with chronic liver diseases including liver cirrhosis and hepatocellular carcinoma. Occurrence of gastric varices (GV) rupture is less often than esophageal varices (EV) but it is characteristic of higher rebleeding rate and mortality and represents an even tougher problem than EV hemorrhage. Endoscopic treatment is an alternative in the management of GV bleeding. Injection sclerotherapy has been applied to arrest GV hemorrhage but it is associated with a high rebleeding rate (50~90%) and thus is regarded as only a temporary hemostatic measure. The advantage of endoscopic variceal ligation is not suggested due to its high rebleeding rate more than 50%. Endoscopic injection of N-butyl-2-cyanoacrylate, a so-called "tissue glue",is more effective to treat GV bleeding because of more than 90% successful rate to arrest acute bleeding. The theoretical advantages of tissue glue derives from its unique ability to plug the varix lumen immediately after injection into varices. However, its rebleeding rate is still high around 30~40% and has potential treatment-related morbidity such as embolic and septic complications. Regardless of these disadvantage, the guideline form major international society and Bavenoconsensus recommend GVO as the first treatment of choice for GV bleeding. Therefore how to prevent the potential complications and reduce rebleedingremains an important and practical issue.
With regarding to potential septic infections and rebleeding, the effects of impaired leukocyte function in cirrhotic patients and reduced immunity and increased gut permeability of severe hemorrhagic patients were contributory. In these immunocompromised hosts, when invasive procedure such as GVO is deployed for these patients, the septic complication become un-neglectable, We found (Gastrointest Endosc 2001) more than 1/3 patients undergoing GVO may complicated with bacteremia. Although most of these bacteremia were self-limited, 2% died of sepsis. Moreover, lots of cases were reported due to persistent and recurrent bacterial infections caused by GVO. Antibiotic prophylaxis has been suggested as an integral part for the management of cirrhotic patients with acute varicealbleeding by major international society and Baveno consensus. However, there is no evidence to suggest antibiotic prophylaxis for the patients treated by elective GVO. Therefore we design a randomized trial to clarify the necessity of antibiotic prophylaxis for the patients chronic liver disease with gastric varices treated by elective GVO.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Varix, Sepsis, Liver Cirrhoses, Fever
Keywords
Gastric variceal rebleeding, Sepsis, cyanoacrylate injection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antibiotic
Arm Type
Experimental
Arm Description
Participate will be acepted ertapenem(1g) iv before endoscopic cyanoacrylate injection obliteration
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participate will not be acepted ertapenem(1g) iv before endoscopic cyanoacrylate injection obliteration
Intervention Type
Drug
Intervention Name(s)
Ertapenem
Other Intervention Name(s)
Invanz
Intervention Description
inject from iv drip before endoscopic cyanoacrylateinjection obliteration
Primary Outcome Measure Information:
Title
Prevetion of sepsis
Description
If Antibiotic Prophylaxis can reduce sepsis in Patients Undergoing GVO
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Rebleeding rate
Description
If Antibiotic Prophylaxis can reduce GV rebleeding rate
Time Frame
3 years
Title
Pevention of Refractory bacterial infection
Description
If Antibiotic Prophylaxis can reduce infection rate in Patients Undergoing GVO
Time Frame
3 years
Title
Mortality
Description
If Antibiotic Prophylaxis can decrease mortality in Patients Undergoing GVO
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with live cirrhosis and/or hepatoma
Aged 20 to 85, who had endoscopy-treatment EV(-)GV(+)or EV<GV
Exclusion Criteria:
Had a terminal illness of any major organ system,such as heart failure, kindey failure,COPD
Patients recieve antibiotics recently.
Patients suspected infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Chih Hou, MD
Phone
886-2-28712111
Ext
7877
Email
mchou@vghtpe.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Chang Lee, MD
Phone
886-2-28712111
Ext
3972
Email
pclee7@vghtpe.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Chih Hou
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veteran General Hospital-Taipei
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Chih Hou
12. IPD Sharing Statement
Plan to Share IPD
No
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Antibiotic Prophylaxis in Patients Undergoing GVO
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