The 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, China
NCT Number: NCT06437964
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Hangzhou, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Cirrhotic patients having a history of gastroesophageal variceal bleeding are readmitted for endoscopic secondary prevention.
Exclusion criteria
Withdraw Criteria:
In the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding, do not use any antibiotics before the endoscopic operation.
Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy
Time frame: From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.
Have fever (>37.5℃) in hospital afer the endoscopic operation
Time frame: Within 4 weeks since the endoscopic operation
Have gastroesophageal variceal bleeding within 4 weeks 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.
Received additional antibiotics after the endoscopic operation
Time frame: From the date of endoscopic operation until the date of hospital discharge, assessed up to 7 days.
Hospital stay (days) after the endoscopic operation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
The Use of Prophylactic Antibiotics in the Endoscopic Secondary Prevention of Cirrhotic Patients With Gastroesophageal Variceal Bleeding
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