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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07616466
Enrollment
480
Registered
2026-06-01
Start date
2024-01-01
Completion date
2026-03-29
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver Hypertension, Portal Variceal Hemorrhage

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.

Interventions

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

Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative bacterial infectionFrom 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

MeasureTime frameDescription
Three-month rebleedingWithin 3 months since the endoscopic operationPresence of overt hemorrhage, including hematemesis, hematochezia, or melena, due to varices within 3 months following the endoscopic intervention.
Post-operative hospitalization daysFrom the date of endoscopic operation until the date of hospital discharge, assessed up to 7 days.Hospital stay (days) after the endoscopic operation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026