Cirrhosis, LiverNCT06437964
Prophylactic Antibiotics in Endoscopic Secondary Prevention of Gastroesophageal Variceal Bleeding
A study testing No use of prophylactic antibiotics and Prophylactic Antibiotics in people with Cirrhosis, Liver and Hypertension, Portal, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhosis, Liver, Hypertension, Portal, Variceal Hemorrhage
- What is being tested?
- No use of prophylactic antibiotics and Prophylactic Antibiotics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2024to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhotic patients having a history of gastroesophageal variceal bleeding are readmitted for endoscopic secondary prevention.
Who cannot join
- Age <18, or ≥81.
- The patient is unwilling to sign the informed consent form.
- Allergy to cephalosporin.
- Have granulocyte deficiency (neutrophil count ≤ 0.5 * 10 ^ 9/L, or white blood cell count ≤ 1.0 * 10 ^ 9/L) before the endoscopic operation.
- Already have infection or fever (body temperature > 37.5 ℃) before signing the informed consent form.
- Withdraw Criteria:
Show all 10Show fewer
- The patient turned back after signing the consent, and before the endoscopic operation.
- Have fever (body temperature > 37.5 ℃) after signing the consent, and before the endoscopic operation.
- 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.).
- The patient suffered massive bleeding during the endoscopy, and cephalosporin was given immediately after being sent back to the ward.
Trial locations and contacts
1 site in 1 country.
China1 site
The 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou
About this study
Official title: 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.
Read the 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.
- Conditions
- Cirrhosis, Liver, Hypertension, Portal, Variceal Hemorrhage
- Being tested
- No use of prophylactic antibiotics, Prophylactic Antibiotics
- Keywords
- Gastroesophageal Variceal Bleeding, Endoscopic Secondary Prevention, Prophylactic Antibiotics
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No use of prophylactic antibioticsOther
In the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding, do not use any antibiotics before the endoscopic operation.
Prophylactic AntibioticsDrug
Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic antibiotics | Active comparator | Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy Receives: Drug: Prophylactic Antibiotics |
| No prophylactic antibiotics | Experimental | No use of prophylactic antibiotics before endoscopic therapy Receives: Other: No use of prophylactic antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative fever
Have fever (>37.5℃) in hospital afer the endoscopic operation
Measured: From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.
Secondary outcomes (3)
Postoperative 4-week rebleeding
Have gastroesophageal variceal bleeding within 4 weeks after the endoscopic operation
Measured: Within 4 weeks since the endoscopic operation
Additional use of antibiotics
Received additional antibiotics after the endoscopic operation
Measured: From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.
Postoperative hospital stays
Hospital stay (days) after the endoscopic operation
Measured: From the date of endoscopic operation until the date of hospital discharge, assessed up to 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start25 May 2024
- Primary completion15 Jan 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng Xue, PhD, Principal investigator, Second Affiliated Hospital, School of Medicine, ZhejiangUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437964
- Sponsor's protocol ID
- 2024-0629
- Status last verified
- May 2026
- First submitted
- 26 May 2024
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Prophylactic Antibiotics in the Endoscopic Secondary Prevention of Cirrhotic Patients With Gastroesophageal Variceal Bleeding
- ClinicalTrials.gov ID
- NCT06437964
- Acronym / sponsor ID
- 2024-0629
- Conditions
- Cirrhosis, Liver, Hypertension, Portal, Variceal Hemorrhage
- Keywords
- Gastroesophageal Variceal Bleeding, Endoscopic Secondary Prevention, Prophylactic Antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 25 May 2024 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic antibiotics | Active comparator | Drug: Prophylactic AntibioticsIntravenous infusion of 2.0g ceftriaxone before endoscopic therapy |
| No prophylactic antibiotics | Experimental | Other: No use of prophylactic antibioticsNo use of prophylactic antibiotics before endoscopic therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cirrhotic patients having a history of gastroesophageal variceal bleeding are readmitted for endoscopic secondary prevention.
Key exclusion criteria (10 listed)
- Age <18, or ≥81.
- The patient is unwilling to sign the informed consent form.
- Allergy to cephalosporin.
- Have granulocyte deficiency (neutrophil count ≤ 0.5 * 10 ^ 9/L, or white blood cell count ≤ 1.0 * 10 ^ 9/L) before the endoscopic operation.
- Already have infection or fever (body temperature > 37.5 ℃) before signing the informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No use of prophylactic antibioticsIn the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding, do not use any antibiotics before the endoscopic operation. | Other | No prophylactic antibiotics |
| Prophylactic AntibioticsIntravenous infusion of 2.0g ceftriaxone before endoscopic therapy | Drug | Prophylactic antibiotics |
Primary outcome
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
3 secondary outcomes
Postoperative 4-week rebleeding
Time frame: 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.
Postoperative hospital stays
Time frame: From the date of endoscopic operation until the date of hospital discharge, assessed up to 7 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng Xue, PhD principal investigator
Second Affiliated Hospital, School of Medicine, ZhejiangUniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No use of prophylactic antibiotics and Prophylactic Antibiotics in people with Cirrhosis, Liver and Hypertension, Portal, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative fever (time frame: From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.