ABX-GV: Antibiotic Prophylaxis in Patients Undergoing GVO

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04140578

Collaborator

(none)

150

Enrollment

Location

Arms

167.1

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Varix Sepsis Liver Cirrhoses Fever	Drug: Ertapenem	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Antibiotic Prophylaxis in Patients Undergoing Endoscopic Injection of Cyanoacrylate for Primary and Secondary Prevention of Gastric Variceal Bleeding

Actual Study Start Date :

Jan 28, 2017

Anticipated Primary Completion Date :

Dec 31, 2030

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Antibiotic Participate will be acepted ertapenem(1g) iv before endoscopic cyanoacrylate injection obliteration	Drug: Ertapenem inject from iv drip before endoscopic cyanoacrylateinjection obliteration Other Names: Invanz
No Intervention: Control Participate will not be acepted ertapenem(1g) iv before endoscopic cyanoacrylate injection obliteration

Arm

Intervention/Treatment

Experimental: Antibiotic

Participate will be acepted ertapenem(1g) iv before endoscopic cyanoacrylate injection obliteration

Drug: Ertapenem

inject from iv drip before endoscopic cyanoacrylateinjection obliteration

Other Names:

Invanz

No Intervention: Control

Participate will not be acepted ertapenem(1g) iv before endoscopic cyanoacrylate injection obliteration

Outcome Measures

Primary Outcome Measures

Prevetion of sepsis [3 years]
If Antibiotic Prophylaxis can reduce sepsis in Patients Undergoing GVO

Secondary Outcome Measures

Rebleeding rate [3 years]
If Antibiotic Prophylaxis can reduce GV rebleeding rate
Pevention of Refractory bacterial infection [3 years]
If Antibiotic Prophylaxis can reduce infection rate in Patients Undergoing GVO
Mortality [3 years]
If Antibiotic Prophylaxis can decrease mortality in Patients Undergoing GVO

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.