Prophylactic Antibiotics in Endoscopic Secondary Prevention of Gastroesophageal Variceal Bleeding
- Conditions
- Variceal HemorrhageHypertension, PortalCirrhosis, Liver
- Interventions
- Drug: Prophylactic AntibioticsOther: No use of prophylactic antibiotics
- Registration Number
- NCT06437964
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 224
Cirrhotic patients with a history of gastroesophageal variceal bleeding that are readmitted for endoscopic secondary prevention, and are willing to sign an informed consent form.
- Allergy to cephalosporin.
- The patient is unwilling to sign the informed consent form.
- Already have concurrent infection before the endoscopic operation.
- Already have fever (body temperature > 37.5 ℃) before the endoscopic operation.
- Have granulocyte deficiency (neutrophil count below 0.5 * 10 ^ 9/L) before the endoscopic operation.
- Have massive pleural effusion or ascites before the endoscopic operation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prophylactic antibiotics Prophylactic Antibiotics Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy No prophylactic antibiotics No use of prophylactic antibiotics No use of prophylactic antibiotics before endoscopic therapy Prophylactic antibiotics No use of prophylactic antibiotics Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy No prophylactic antibiotics No use of prophylactic antibiotics No use of prophylactic antibiotics before endoscopic therapy
- Primary Outcome Measures
Name Time Method Post-operation infection From the endoscopic operation to hospital discharge Have fever (\>37.5℃) in hospital afer the endoscopic operation
- Secondary Outcome Measures
Name Time Method Post-operation 4-week rebleeding Within 4 weeks since the endoscopic operation Have gastroesophageal variceal bleeding within 4 weeks after the endoscopic operation
Trial Locations
- Locations (1)
The 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
🇨🇳Hangzhou, China