Cirrhosis, Liver Hypertension, Portal Variceal HemorrhageNCT07616466
Prophylactic Antibiotics in the Endoscopic Secondary Prevention of Cirrhotic Patients With Varices: a Retrospective Study
An observational study of Cirrhosis, Liver Hypertension, Portal Variceal Hemorrhage, 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 retrospective study, we are aimed to evaluate whether prophylactic antibiotics confer advantages in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal varices. 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
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 29 Mar 2026
- Phase
- Observational
- 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
Study population: Cirrhotic patients with a history of gastroesophageal variceal bleeding and were readmitted for elective endoscopic treatment.
Who may be able to join
- Cirrhotic patients with a history of gastroesophageal variceal bleeding who were readmitted for elective endoscopic treatment.
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
About this study
Official title: The Use of Prophylactic Antibiotics in the Endoscopic Secondary Prevention of Cirrhotic Patients With Gastoesophageal Varices: a Retrospective Study
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.
- Being tested
- No use of prophylactic antibiotics, Prophylactic Antibiotics
- Medical subject headings
- Fibrosis
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 |
|---|---|---|
| No prophylactic antibiotics | No use of prophylactic antibiotics before endoscopic therapy Receives: Other: No use of prophylactic antibiotics | |
| Prophylactic antibiotics | Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy Receives: Drug: Prophylactic Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.
Secondary outcomes (2)
Three-month rebleeding
Presence of overt hemorrhage, including hematemesis, hematochezia, or melena, due to varices within 3 months following the endoscopic intervention.
Measured: Within 3 months since the endoscopic operation
Post-operative hospitalization days
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 posted1 Jun 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2025
- Study completion29 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, Liver Hypertension, Portal Variceal HemorrhageStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616466
- Sponsor's protocol ID
- 2026-0728
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jun 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 Gastoesophageal Varices: a Retrospective Study
- ClinicalTrials.gov ID
- NCT07616466
- Acronym / sponsor ID
- 2026-0728
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 29 Mar 2026 (actual)
- First posted
- 1 Jun 2026 (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 retrospective study, we are aimed to evaluate whether prophylactic antibiotics confer advantages in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal varices.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No prophylactic antibiotics | – | Other: No use of prophylactic antibioticsNo use of prophylactic antibiotics before endoscopic therapy |
| Prophylactic antibiotics | – | Drug: Prophylactic AntibioticsIntravenous infusion of 2.0g ceftriaxone before endoscopic therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhotic patients with a history of gastroesophageal variceal bleeding and were readmitted for elective endoscopic treatment.
Key inclusion criteria (1 listed)
- Cirrhotic patients with a history of gastroesophageal variceal bleeding who were readmitted for elective endoscopic treatment.
Key exclusion criteria (2 listed)
- (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
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
Post-operative bacterial infection
Time frame: From 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.
2 secondary outcomes
Three-month rebleeding
Time frame: Within 3 months since the endoscopic operation
Post-operative hospitalization days
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 1 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, Liver Hypertension, Portal Variceal Hemorrhage, 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 2 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 1 Jun 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?
Post-operative bacterial infection (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 1 Jun 2026.