Actively Recruiting
Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy
Led by Children's Hospital of Fudan University · Updated on 2024-10-21
356
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is non-inferiority trial design. This study aimed to investigate the effect of prophylactic oral antibiotics on preventing cholangitis in biliary atresia (BA) patients after Kasai portoenterostomy (KP) by comparing the cholangitis rate in BA patients who received prophylactic oral antibiotics and those who did not. The patients were followed up for 2 years after KP.
CONDITIONS
Official Title
Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients whose age of operation is 14-90 days, with no restriction on sex or race
- Patients born with gestational age older than 36 weeks
- Patients whose body weight before operation is greater than 2 kg
- Patients diagnosed with type-III biliary atresia and undergoing Kasai portoenterostomy at Children's Hospital of Fudan University
- Diagnosis of type-III biliary atresia based on cholangiography or operation
- Patients with liver biopsy reports including HE staining and Masson staining showing edema, inflammation, fibrosis, and intrahepatic bile duct hyperplasia
- Patients not allergic to postoperative medications
- Patients who have not received other antibiotic or probiotic therapy before the study
You will not qualify if you...
- Patients with cholestasis due to diseases other than biliary atresia
- Patients who have undergone Kasai portoenterostomy at other institutions
- Patients with uncertain pathohistological diagnosis
- Patients undergoing liver transplantation immediately after Kasai portoenterostomy
- Patients with other liver diseases or severe complications needing surgical or medical intervention (e.g., severe pulmonary hypertension, renal failure, intracranial hemorrhage)
- Patients with severe cardiac, renal, or central nervous system malformations with poor prognosis (e.g., tetralogy of Fallot, transposition of great arteries, cerebral dysplasia)
- Patients judged by researchers to be unable to comply with study requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
Research Team
G
Gong Chen, Phd
CONTACT
D
Di Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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