Prophylactic Antibiotics in Endoscopic Secondary Prevention of Gastroesophageal Variceal Bleeding

May 24, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

The Use of Prophylactic Antibiotics in the Endoscopic Secondary Prevention of Cirrhotic Patients With Gastroesophageal Variceal Bleeding

Whether prophylactic antibiotics should be administered in the endoscopic secondary prevention of GVB or not is unclear. In this non-inferiority trial, we are aimed to evaluate whether prophylactic antibiotics are essential in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prophylactic antibiotics like third-generation cephalosporin is recommended for acute gastroesophageal variceal bleeding (GVB). Endoscopic sequential therapy is an option in the secondary prevention of acute gastroesophageal variceal bleeding (GVB). However, the value of prophylactic antibiotics in the endoscopic secondary prevention of GVB is still unclear. It's assumed that the procedure of needle puncture under endoscopy will cause iatrogenic variceal bleeding. Besides, the surface of intraluminal varices is nonsterile, and injection of sclerosing agent or tissue adhesive will put patients at a risk of bacteremia. As a result, it's rational to use antibiotics prophylactically in the endoscopic sequential therapy of GVB. While giving antibiotics in all patients might cause abuse of antibiotics. In clinical practice now, the prophylactic administration of antibiotics is quite subjective. We observe that quite a lot of cirrhotic patients had no infection after endoscopic secondary prevention for gastroesophageal variceal bleeding, even they have not been administered prophylactic antibiotics. In this non-inferiority trial, we are aimed to evaluate whether no value of prophylactic antibiotics will increase the postoperative infection or not, in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding.

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hangzhou, China
        • The 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Cirrhotic patients having a history of gastroesophageal variceal bleeding are readmitted for endoscopic secondary prevention.

Exclusion Criteria:

  1. Age <18, or ≥81.
  2. The patient is unwilling to sign the informed consent form.
  3. Allergy to cephalosporin.
  4. Have granulocyte deficiency (neutrophil count ≤ 0.5 * 10 ^ 9/L, or white blood cell count ≤ 1.0 * 10 ^ 9/L) before the endoscopic operation.
  5. Already have infection or fever (body temperature > 37.5 ℃) before signing the informed consent form.

Withdraw Criteria:

  1. The patient turned back after signing the consent, and before the endoscopic operation.
  2. Have fever (body temperature > 37.5 ℃) after signing the consent, and before the endoscopic operation.
  3. 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.).
  4. The patient suffered massive bleeding during the endoscopy, and cephalosporin was given immediately after being sent back to the ward.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prophylactic antibiotics
Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy
Drug: Prophylactic Antibiotics
Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative fever
Time Frame: From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.
Have fever (>37.5℃) in hospital afer the endoscopic operation
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
Postoperative 4-week rebleeding
Time Frame: Within 4 weeks since the endoscopic operation
Have gastroesophageal variceal bleeding within 4 weeks after the endoscopic operation
Within 4 weeks since the endoscopic operation
Additional use of antibiotics
Time Frame: From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.
Received additional antibiotics after the endoscopic operation
From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.
Postoperative hospital stays
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
From the date of endoscopic operation until the date of hospital discharge, assessed up to 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Meng Xue, PhD, Second Affiliated Hospital, School of Medicine, ZhejiangUniversity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2024

Primary Completion (Actual)

January 15, 2026

Study Completion (Actual)

February 10, 2026

Study Registration Dates

First Submitted

May 26, 2024

First Submitted That Met QC Criteria

May 26, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 24, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0629

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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