Using antibiotics to prevent bleeding in cirrhotic patients during endoscopy
The Use of Prophylactic Antibiotics in the Endoscopic Secondary Prevention of Cirrhotic Patients With Gastroesophageal Variceal Bleeding
This study tests if giving antibiotics to cirrhotic patients during endoscopy helps prevent infections after they have treatment for bleeding varices compared to not using antibiotics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou) |
| Trial ID | NCT06437964 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the necessity of prophylactic antibiotics in cirrhotic patients undergoing endoscopic secondary prevention for gastroesophageal variceal bleeding (GVB). It aims to determine if avoiding antibiotics increases the risk of postoperative infections. The study compares outcomes between patients receiving prophylactic antibiotics and those who do not, focusing on infection rates post-procedure. The trial is designed as a non-inferiority study to assess the safety and effectiveness of this approach.
Who should consider this trial
Good fit: Ideal candidates are cirrhotic patients with a history of gastroesophageal variceal bleeding who are being readmitted for endoscopic secondary prevention.
Not a fit: Patients with allergies to cephalosporins, concurrent infections, or significant pre-existing health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored antibiotic use, reducing unnecessary antibiotic exposure in cirrhotic patients.
How similar studies have performed: While the use of prophylactic antibiotics in acute GVB has been established, the specific approach of this trial is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Cirrhotic patients with a history of gastroesophageal variceal bleeding that are readmitted for endoscopic secondary prevention, and are willing to sign an informed consent form. Exclusion Criteria: 1. Allergy to cephalosporin. 2. The patient is unwilling to sign the informed consent form. 3. Already have concurrent infection before the endoscopic operation. 4. Already have fever (body temperature \> 37.5 ℃) before the endoscopic operation. 5. Have granulocyte deficiency (neutrophil count below 0.5 \* 10 \^ 9/L) before the endoscopic operation. 6. Have massive pleural effusion or ascites before the endoscopic operation.
Where this trial is running
Hangzhou
- The 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, China (Recruiting)
Study contacts
- Principal investigator: Meng Xue, PhD — Second Affiliated Hospital, School of Medicine, ZhejiangUniversity
- Study coordinator: Meng Xue, PhD
- Email: xuemeng@zju.edu.cn
- Phone: 13958123617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.