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Antibiotics before endoscopy: necessary or not for cirrhosis patients?

NCT ID NCT06437964

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether giving antibiotics before an endoscopic procedure helps prevent fever and rebleeding in people with cirrhosis who have had variceal bleeding before. 226 patients were randomly assigned to receive the antibiotic ceftriaxone or no antibiotics before the procedure. The goal was to see if skipping antibiotics is just as safe (non-inferior) as using them.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ceftriaxone (an antibiotic)
What this could lead to
If successful, this could show that skipping antibiotics before endoscopy is safe for some cirrhosis patients, reducing unnecessary drug use.
What could go wrong
This is a small, completed trial with only 226 participants. Results may not apply to all patients, and skipping antibiotics could raise infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

226 people

The number who actually took part.

Started

May 2024

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver esophageal varices with bleeding portal hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cirrhosis, liver Hypertension, portal Variceal hemorrhage

Contacts and locations

Locations

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

    Hangzhou, China

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