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

NCT07616466 | Completed DMC

• 1 other identifier: 2026-0728
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis, Liver Hypertension, Portal Variceal Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Three-month rebleeding

  Within 3 months since the endoscopic operation

• Post-operative hospitalization days

  From the date of endoscopic operation until the date of hospital discharge, assessed up to 7 days.

Study Arms (2)

No prophylactic antibiotics

No use of prophylactic antibiotics before endoscopic therapy

Other: No use of prophylactic antibiotics

Prophylactic antibiotics

Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy

Drug: Prophylactic Antibiotics

Interventions

No use of prophylactic antibiotics OTHER

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

No prophylactic antibiotics

Prophylactic Antibiotics DRUG

Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy

Prophylactic antibiotics

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• (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

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 1, 2026
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 29, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)