Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy

Recruiting now · Not applicable

Conditions studied: Biliary Atresia, Cholangitis, Anti-Bacterial Agents

In brief

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.

Key facts

Study ID

NCT05925309

Run by

Children's Hospital of Fudan University

People needed

356

Starts

2023-07-01

Expected to finish

2029-12-31

Last updated by the study team

2026-05-15

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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