Prophylactic Antibiotics in Endoscopic Secondary Prevention of Gastroesophageal Variceal Bleeding

Cirrhosis, Liver Clinical Trial

Official title:

The Use of Prophylactic Antibiotics in the Endoscopic Secondary Prevention of Cirrhotic Patients With Gastroesophageal Variceal Bleeding

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06437964
• Other study ID #: 2024-0629
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 antibotics 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 administed 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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 224
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

1. Allergy to penicillin or cephalosporin.

2. The patient is unwilling to sign the informed consent form.

3. Already have concurrent infection before the endoscopic operation.

4. Already have fever (body temperature = 37.5 ?) before the endoscopic operation.

5. Have granulocyte deficiency (neutrophil count below 0.5 * 10 ^ 9/L) before the endoscopic operation.

6. Have malignant tumors before the endoscopic operation.

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Hemorrhage
• Liver Cirrhosis
• Neoplasm Metastasis

Intervention

Other:
• No use of prophylactic antibiotics
In the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding, do not use any antibiotics before the endoscopic operation.

Locations

Country	Name	City	State
China	The 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operation infection	have fever and increased inflammation marker within one day afer the endoscopic operation	19 months
Secondary	Post-operation 4-week rebleeding	have gastroesophageal variceal bleeding within 4 week after the endoscopic operation	19 months