Actively Recruiting
Antibiotic Prophylaxis in Patients Undergoing Endoscopic Injection of Cyanoacrylate for Primary and Secondary Prevention of Gastric Variceal Bleeding
Led by Taipei Veterans General Hospital, Taiwan · Updated on 2019-10-28
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the need for antibiotic prevention in patients with chronic liver disease who have gastric varices and are treated with elective endoscopic injection of cyanoacrylate (GVO). Gastric varices can cause serious bleeding with a high chance of rebleeding and mortality. While endoscopic injection of tissue glue is effective in stopping acute bleeding, it still carries risks of rebleeding and infection, which are important concerns for patients with weakened immune systems due to liver conditions. The study compares two groups: one receiving an antibiotic called ertapenem injected intravenously before the endoscopic cyanoacrylate injection, and the other not receiving this antibiotic before the procedure. The trial is randomized and aims to clarify whether giving this antibiotic can help prevent infections and complications after GVO treatment. The treatment is delivered during an elective endoscopic procedure to manage gastric varices. Participants will be monitored for three years to evaluate key outcomes such as the prevention of sepsis, rebleeding rates, refractory bacterial infections, and mortality. Assessments will include tracking infections and bleeding events over time. The study is designed to provide long-term data on the benefits and risks of using antibiotic prophylaxis in this patient group, with ongoing safety monitoring throughout the follow-up period.
CONDITIONS
Brief Title
Antibiotic Prophylaxis in Patients Undergoing GVO
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with liver cirrhosis and/or hepatoma
- Aged 20 to 85 years
- Have had endoscopic treatment showing absence of esophageal varices and presence of gastric varices or gastric varices larger than esophageal varices
You will not qualify if you...
- Terminal illness of any major organ system such as heart failure, kidney failure, or COPD
- Patients who have recently received antibiotics
- Patients suspected to have an infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day of treatment
Participants receive an intravenous dose of ertapenem antibiotic before undergoing endoscopic cyanoacrylate injection obliteration, or no antibiotic if assigned to the control group.
1 treatment visit (in-person)
Duration - Up to 3 years
Participants are monitored for up to 3 years after treatment to assess prevention of sepsis, rebleeding rate, bacterial infections, and mortality.
Periodic follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Veteran General Hospital-Taipei
Taipei, Taiwan
Actively Recruiting
Research Team
M
Ming-Chih Hou, MD
P
Pei-Chang Lee, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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