Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy

Launched by CHILDREN'S HOSPITAL OF FUDAN UNIVERSITY · Jun 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether taking preventive oral antibiotics can help reduce the risk of cholangitis, an infection of the bile ducts, in patients with biliary atresia (BA) after a surgical procedure called Kasai portoenterostomy (KP). The trial will compare two groups of patients: those who receive the antibiotics and those who do not, to see if there is a difference in the rate of cholangitis over a two-year follow-up period.

To be eligible for this study, participants should be between 14 and 90 days old, have been diagnosed with type-III biliary atresia, and have undergone the KP surgery at the Children's Hospital of Fudan University. It's important that they have not received any other antibiotic or probiotic treatments before joining the trial. Participants can expect regular follow-ups to monitor their health and any signs of infection. Overall, this study aims to determine if these antibiotics can be a helpful preventive measure for young patients facing this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients whose age of operation is 14-90 d. Sex and race are not restricted;
• • Patients who are born with gestational age older than 36 weeks;
• • Patients whose body weight before operation \> 2 kg;
• • Patients diagnosed of type-III BA and underwent KP in Children's Hospital of Fudan University;
• • The type-III BA diagnosis is based on cholangiography or operation;
• • Patients whose histological features of liver biopsies are reported. HE staining and Masson staining are required, and edema, inflammation, fibrosis, and hyperplasia of intrahepatic bile duct should be reported;
• • Patients who are not allergic to postoperative medications;
• • Patients who haven't accepted other antibiotic or probiotic therapy.
• Exclusion Criteria:
• • Patients with cholestasis of non-BA disease;
• • Patients who have undergone KP at other institutions;
• • Patients whose pathohistological diagnosis is in doubt;
• • Patients who undergo liver transplantation immediately after KP;
• • Patients with other liver diseases or severe complications (e.g., severe pulmonary hypertension, renal failure, intracranial hemorrhage, etc.) requiring surgical intervention or other medical therapy;
• • Patients with severe cardiac, renal, or central nerve system malformations (e.g., tetralogy of Fallot, transposition of the great arteries, cerebral dysplasia, etc.) and have poor prognosis;
• • Patients judged by the researchers that they can not comply with the study requirements.