Antibiotic Prophylaxis in Patients Undergoing GVO (ABX-GV)

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

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 Overview

• Status: Recruiting
• Conditions: Sepsis; Fever; Liver Cirrhoses; Gastric Varix
• Intervention / Treatment: Drug: Ertapenem

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Veteran General Hospital-Taipei
    • Contact: Ming-Chih Hou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with live cirrhosis and/or hepatoma
2. Aged 20 to 85, who had endoscopy-treatment EV(-)GV(+)or EV<GV

Exclusion Criteria:

1. Had a terminal illness of any major organ system,such as heart failure, kindey failure,COPD
2. Patients recieve antibiotics recently.
3. Patients suspected infection.

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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevetion of sepsis	If Antibiotic Prophylaxis can reduce sepsis in Patients Undergoing GVO	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rebleeding rate	If Antibiotic Prophylaxis can reduce GV rebleeding rate	3 years
Pevention of Refractory bacterial infection	If Antibiotic Prophylaxis can reduce infection rate in Patients Undergoing GVO	3 years
Mortality	If Antibiotic Prophylaxis can decrease mortality in Patients Undergoing GVO	3 years

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Ming-Chih Hou, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2017
• Primary Completion (Anticipated): December 31, 2030
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: cyanoacrylate injection; Sepsis; Gastric variceal rebleeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Liver Diseases; Fibrosis; Esophageal Diseases; Hypertension, Portal; Liver Cirrhosis; Esophageal and Gastric Varices; Anti-Infective Agents; Anti-Bacterial Agents; Ertapenem
• Other Study ID Numbers: 2017-01-027C

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No