Sepsis Clinical Trial
Official title:
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.
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.
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