Using oral antibiotics to prevent cholangitis after liver surgery in infants

Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy in Biliary Atresia: a Randomized Controlled Trial

This study is testing if giving oral antibiotics to infants after liver surgery can help prevent cholangitis, compared to those who don’t receive the antibiotics.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 356 (estimated)
• Ages: 14 Days to 90 Days
• Sex: All
• Sponsor: Children's Hospital of Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05925309 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are infants aged 14 to 90 days diagnosed with type-III biliary atresia who have undergone Kasai portoenterostomy.

Not a fit: Patients with cholestasis due to non-biliary atresia diseases or those who have undergone surgery at other institutions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of cholangitis in biliary atresia patients, improving their overall health outcomes.

How similar studies have performed: While there is ongoing debate regarding the use of prophylactic antibiotics in similar contexts, high-quality evidence supporting their effectiveness remains limited, making this approach relatively novel.

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.

Where this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Study coordinator: Gong Chen, Phd

Conditions Biliary Atresia; Cholangitis; Anti-Bacterial Agents