Using oral antibiotics to prevent cholangitis after liver surgery in infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of prophylactic oral antibiotics in preventing cholangitis in infants with biliary atresia after undergoing Kasai portoenterostomy. It is designed as a non-inferiority trial, comparing the rates of cholangitis in patients who receive antibiotics versus those who do not. The study will follow patients for two years post-surgery to assess outcomes. Given the high incidence of cholangitis and the variability in antibiotic use, this research aims to provide high-quality evidence regarding the benefits and risks of long-term antibiotic prophylaxis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Gong Chen, Phd
• Email: chengongzlp@hotmail.com
• Phone: (+86)13918330650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.