Veteran General Hospital-Taipei
Taipei, Taiwan
Location status: Recruiting
Location contact
Ming-Chih Hou
CONTACT
NCT Number: NCT04140578
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.
Interested in participating?
Request Info20 year–85 year
All sexes
Interventional
Phase 4
Taipei, Taiwan
Location status: Recruiting
Ming-Chih Hou
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
inject from iv drip before endoscopic cyanoacrylateinjection obliteration
Other names: Invanz
Time frame: 3 years
If Antibiotic Prophylaxis can reduce sepsis in Patients Undergoing GVO
Time frame: 3 years
If Antibiotic Prophylaxis can reduce GV rebleeding rate
Time frame: 3 years
If Antibiotic Prophylaxis can reduce infection rate in Patients Undergoing GVO
Time frame: 3 years
If Antibiotic Prophylaxis can decrease mortality in Patients Undergoing GVO
Contact information is provided by the study sponsor or research team.
Ming-Chih Hou, MD
CONTACT
886-2-28712111 ext. 7877
Pei-Chang Lee, MD
CONTACT
886-2-28712111 ext. 3972
Taipei Veterans General Hospital, Taiwan
Other Gov
Antibiotic Prophylaxis in Patients Undergoing Endoscopic Injection of Cyanoacrylate for Primary and Secondary Prevention of Gastric Variceal Bleeding
Acronym: ABX-GV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03748563
Digestive System Diseases, Esophageal Diseases
Guangzhou, Guangdong, China
View Trial DetailsNCT04828369
Digestive System Diseases, Esophageal Diseases
Wuhan, Hubei, China
View Trial DetailsNCT03155256
Digestive System Diseases, Esophageal Diseases
Guayaquil, Guayas, Ecuador
View Trial DetailsNCT06637904
Arrhythmias, Cardiac, Body Temperature Changes
Peoria, Illinois, United States
View Trial Details