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Completed

NCT Number: NCT07616466

Prophylactic Antibiotics in the Endoscopic Secondary Prevention of Cirrhotic Patients With 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.

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Key information

Conditions

Cirrhosis, Liver Hypertension, Portal Variceal Hemorrhage Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Prophylactic Antibiotics

Drug

Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy

Primary outcomes

  1. Post-operative bacterial infection

    Time frame: From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.

    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.

Secondary outcomes

  1. Three-month rebleeding

    Time frame: Within 3 months since the endoscopic operation

    Presence of overt hemorrhage, including hematemesis, hematochezia, or melena, due to varices within 3 months following the endoscopic intervention.

  2. Post-operative hospitalization days

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

    Hospital stay (days) after the endoscopic operation

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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