Whether prophylactic antibiotics should be administered in the endoscopic secondary prevention of GVB or not is unclear. In this non-inferiority trial, we are aimed to evaluate whether prophylactic antibiotics are essential in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding.
Prophylactic antibiotics like third-generation cephalosporin is recommended for acute gastroesophageal variceal bleeding (GVB). Endoscopic sequential therapy is an option in the secondary prevention of acute gastroesophageal variceal bleeding (GVB). However, the value of prophylactic antibiotics in the endoscopic secondary prevention of GVB is still unclear. It's assumed that the procedure of needle puncture under endoscopy will cause iatrogenic variceal bleeding. Besides, the surface of intraluminal varices is nonsterile, and injection of sclerosing agent or tissue adhesive will put patients at a risk of bacteremia. As a result, it's rational to use antibiotics prophylactically in the endoscopic sequential therapy of GVB. While giving antibiotics in all patients might cause abuse of antibiotics. In clinical practice now, the prophylactic administration of antibiotics is quite subjective. We observe that quite a lot of cirrhotic patients had no infection after endoscopic secondary prevention for gastroesophageal variceal bleeding, even they have not been administered prophylactic antibiotics. In this non-inferiority trial, we are aimed to evaluate whether no value of prophylactic antibiotics will increase the postoperative infection or not, in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
226
In the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding, do not use any antibiotics before the endoscopic operation.
Intravenous infusion of 1.0g-2.0g ceftriaxone before endoscopic therapy
The 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, China
Postoperative fever
Have fever (\>37.5℃) in hospital afer the endoscopic operation
Time frame: From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.
Postoperative 4-week rebleeding
Have gastroesophageal variceal bleeding within 4 weeks after the endoscopic operation
Time frame: Within 4 weeks since the endoscopic operation
Additional use of antibiotics
Received additional antibiotics after the endoscopic operation
Time frame: From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.
Postoperative hospital stays
Hospital stay (days) after the endoscopic operation
Time frame: From the date of endoscopic operation until the date of hospital discharge, assessed up to 7 days.
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