Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-90
SponsorChildren's Hospital of Fudan University
About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem
- Prophylactic oral antibiotics: compound sulfamethoxazole tablet (SMZ/TMP) + cefaclor
Treatment groups
356 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov