Prophylactic Antibiotics in the Endoscopic Secondary Prevention of Cirrhotic Patients With Varices: a Retrospective Study

The Use of Prophylactic Antibiotics in the Endoscopic Secondary Prevention of Cirrhotic Patients With Gastoesophageal Varices: a Retrospective Study

Whether prophylactic antibiotics should be administered in the endoscopic secondary prevention of GVB or not is unclear. In this retrospective study, we are aimed to evaluate whether prophylactic antibiotics confer advantages in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal varices.

Study Overview

• Status: Completed
• Conditions: Cirrhosis, Liver Hypertension, Portal Variceal Hemorrhage
• Intervention / Treatment: Other: No use of prophylactic antibiotics; Drug: Prophylactic Antibiotics

• Study Type: Observational
• Enrollment (Actual): 480

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Cirrhotic patients with a history of gastroesophageal variceal bleeding and were readmitted for elective endoscopic treatment.

Description

Inclusion Criteria:

• Cirrhotic patients with a history of gastroesophageal variceal bleeding who were readmitted for elective endoscopic treatment.

Exclusion Criteria:

• (1) Age < 18 or ≥ 81 years; (2) Allergy to cephalosporin; (3) Agranulocytosis (neutrophil count < 0.5 × 10^9/L); (4) Massive ascites; and (5) Signs of bacteria infection.

Withdraw Criteria:（1）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.). （2）Lost to follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No prophylactic antibiotics; No use of prophylactic antibiotics before endoscopic therapy	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.
Prophylactic antibiotics; Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy	Drug: Prophylactic Antibiotics; Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative bacterial infection	Defined as one of the following conditions: (1) Bacteremia: presence of a positive blood culture without definite infectious focus. (2) Spontaneous bacterial peritonitis: Ascitic fluid polymorphonuclear cell count > 250/mm³ with a positive ascitic culture, or polymorphonuclear cell count > 500/mm³ when ascitic culture is negative. (3) Pulmonary infection: Confirmed by the presence of pneumonic patches or pleural effusion on pulmonary CT. (4) Urinary tract infection: Abnormal urinary sediment (>15 leukocytes/ high power field) with a positive urine culture. (5) Possible infection: Unexplained fever > 37.5°C lasting for more than 6 hours, combined with increased inflammatory index (White blood cell > 15, 000/mm3, Neutrophil percentage > 70%, or C-reactive protein > 10mg/L), but with negative blood cultures.	From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Three-month rebleeding	Presence of overt hemorrhage, including hematemesis, hematochezia, or melena, due to varices within 3 months following the endoscopic intervention.	Within 3 months since the endoscopic operation
Post-operative hospitalization days	Hospital stay (days) after the endoscopic operation	From the date of endoscopic operation until the date of hospital discharge, assessed up to 7 days.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): March 29, 2026

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: May 24, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis
• Other Study ID Numbers: 2026-0728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No