NCT05925309 Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy
| NCT ID | NCT05925309 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Biliary Atresia |
| Study Type | INTERVENTIONAL |
| Enrollment | 356 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 356 participants in total. It began in 2023-07-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05925309 clinical trial?
This trial is open to participants of all sexes, aged 14 Days or older, up to 90 Days, studying Biliary Atresia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05925309 currently recruiting?
Yes, NCT05925309 is actively recruiting participants. Contact the research team at chengongzlp@hotmail.com for enrollment information.
Where is the NCT05925309 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05925309 clinical trial?
NCT05925309 is sponsored by Children's Hospital of Fudan University. The trial plans to enroll 356 participants.