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CompletedNCT07616466Updated Jun 1, 2026

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

An observational study in Cirrhosis, Liver Hypertension, Portal Variceal Hemorrhage, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
480
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Cirrhosis, Liver Hypertension, Portal Variceal Hemorrhage

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03

In context

Fibrosis

3,255 studies on the registry are indexed under Fibrosis; 465 are open to participants now.

This study's enrollment of 480 is above the median of 110 across 973 observational studies indexed under Fibrosis.

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Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

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

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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
480 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNo 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.

  • DrugProphylactic Antibiotics

    Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy

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What researchers measure

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.

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

Secondary outcomes

  1. Three-month rebleeding

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

    Time frame: Within 3 months since the endoscopic operation

  2. Post-operative hospitalization days

    Hospital stay (days) after the endoscopic operation

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

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Study locations

1 site
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
    Hangzhou, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07616466
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Jun 1, 2026
Start date
Jan 1, 2024
Primary completion
Dec 31, 2025
Completion
Mar 29, 2026
Last update
Jun 1, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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