Prophylactic Antibiotics in Endoscopic Secondary Prevention of Gastroesophageal Variceal Bleeding

NCT ID: NCT06437964

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-25
• Study Completion Date: 2026-02-10

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.

Conditions

Cirrhosis, Liver; Hypertension, Portal; Variceal Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prophylactic antibiotics

Intravenous infusion of 1.0g-2.0g ceftriaxone before endoscopic therapy

Group Type: ACTIVE_COMPARATOR

Prophylactic Antibiotics

Intervention Type: DRUG

Intravenous infusion of 1.0g-2.0g ceftriaxone before endoscopic therapy

No prophylactic antibiotics

No use of prophylactic antibiotics before endoscopic therapy

Group Type: EXPERIMENTAL

No use of prophylactic antibiotics

Intervention Type: OTHER

In the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding, do not use any antibiotics before the endoscopic operation.

Interventions

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.

Intervention Type: OTHER

Prophylactic Antibiotics

Intravenous infusion of 1.0g-2.0g ceftriaxone before endoscopic therapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Cirrhotic patients having a history of gastroesophageal variceal bleeding are readmitted for endoscopic secondary prevention.

Exclusion Criteria

1. Age <18, or ≥81.

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

3. Allergy to cephalosporin.

4. Have granulocyte deficiency (neutrophil count ≤ 0.5 * 10 ^ 9/L, or white blood cell count ≤ 1.0 * 10 ^ 9/L) before the endoscopic operation.

5. Already have infection or fever (body temperature > 37.5 ℃) before signing the informed consent form.

Withdraw Criteria:

1. The patient turned back after signing the consent, and before the endoscopic operation.

2. Have fever (body temperature > 37.5 ℃) after signing the consent, and before the endoscopic operation.

3. Transferred to other department for additional treatment after the endoscopic operation (Surgical department for malignant tumor, Interventional radiology department for splenic embolism or transjugular intrahepatic portosystemic shunt, etc.).

4. The patient suffered massive bleeding during the endoscopy, and cephalosporin was given immediately after being sent back to the ward.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meng Xue, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, ZhejiangUniversity

Locations

The 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, , China

Countries

China

Other Identifiers

2024-0629

Identifier Type: -

Identifier Source: org_study_id