Antibiotic Prophylaxis in Patients Undergoing GVO

NCT ID: NCT04140578

Last Updated: 2019-10-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-28
• Study Completion Date: 2030-12-31

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.

Conditions

Gastric Varix; Sepsis; Liver Cirrhoses; Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Antibiotic

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

Group Type: EXPERIMENTAL

Ertapenem

Intervention Type: DRUG

inject from iv drip before endoscopic cyanoacrylateinjection obliteration

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ertapenem

inject from iv drip before endoscopic cyanoacrylateinjection obliteration

Intervention Type: DRUG

Other Intervention Names

Invanz

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming-Chih Hou

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Veteran General Hospital-Taipei

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ming-Chih Hou, MD

Role: CONTACT

mchou@vghtpe.gov.tw

886-2-28712111 ext. 7877

Pei-Chang Lee, MD

Role: CONTACT

pclee7@vghtpe.gov.tw

886-2-28712111 ext. 3972

Facility Contacts

Ming-Chih Hou

Role: primary

Other Identifiers

2017-01-027C

Identifier Type: -

Identifier Source: org_study_id