Using antibiotics to prevent infections in patients with gastric varices undergoing treatment
Antibiotic Prophylaxis in Patients Undergoing Endoscopic Injection of Cyanoacrylate for Primary and Secondary Prevention of Gastric Variceal Bleeding
This study is testing if giving antibiotics to patients with liver disease and gastric varices during treatment can help prevent infections and reduce the chances of bleeding again.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | All |
| Sponsor | Taipei Veterans General Hospital, Taiwan Government |
| Locations | 1 site (Taipei) |
| Trial ID | NCT04140578 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the necessity of antibiotic prophylaxis in patients with chronic liver disease and gastric varices who are treated with endoscopic variceal obturation (GVO). The study will involve a randomized approach to assess the effectiveness of Ertapenem in preventing septic infections and reducing the rebleeding rate associated with gastric variceal bleeding. Given the high rebleeding rates and potential complications from current treatment methods, this trial seeks to clarify the role of antibiotics in improving patient outcomes. Participants will be closely monitored for any adverse effects and treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 20 to 85 with liver cirrhosis or hepatoma who have gastric varices but no esophageal varices.
Not a fit: Patients with terminal illnesses affecting major organ systems, recent antibiotic use, or suspected infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of infections and rebleeding in patients with gastric varices, improving their overall treatment outcomes.
How similar studies have performed: Other studies have explored antibiotic prophylaxis in similar contexts, but this specific approach using Ertapenem in gastric varices is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with live cirrhosis and/or hepatoma 2. Aged 20 to 85, who had endoscopy-treatment EV(-)GV(+)or EV\<GV Exclusion Criteria: 1. Had a terminal illness of any major organ system,such as heart failure, kindey failure,COPD 2. Patients recieve antibiotics recently. 3. Patients suspected infection.
Where this trial is running
Taipei
- Veteran General Hospital-Taipei — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Ming-Chih Hou — Taipei Veterans General Hospital, Taiwan
- Study coordinator: Ming-Chih Hou, MD
- Email: mchou@vghtpe.gov.tw
- Phone: 886-2-28712111
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.