RecruitingNot ApplicableNCT05925309

Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy

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

Sponsor

Children's Hospital of Fudan University

Enrollment

356 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Biliary Atresia Cholangitis Anti-Bacterial Agents

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

Min Age: 14 DaysMax Age: 90 Days

Inclusion Criteria8

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 Criteria7

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.

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Interventions

DRUGBasic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem

Sulperazone 50mg/kg q8h is used intravenously from the first day to the 14th day after KP surgery. Ursodeoxycholic acid 20mg/kg/d p.o, starting from the 5th day after surgery for at least 2 years. Compound glycyrrhizin 20mg/d i.v, 1-4 days after operation, then switch to compound glycyrrhizin tablets 12.5mg b.i.d p.o until 6 months after KP. Methylprednisolone start at 4mg/kg/d i.v on the 8th day after operation, and decrease by 1mg/kg/d every three days. Starting at about the 15th day after operation, methylprednisolone 4mg/kg is given orally every other day, and the dose is gradually reduced at 10-12 weeks. Vitamin AD , D , E , K, are given orally from the 5th day after the KP for at least 2 months. Treatment of cholangitis: sulperazone 50mg/kg q8h i.v., and methylprednisolone could be used. If cholangitis is not controlled, imipenem or meropenem may be used.

DRUGProphylactic oral antibiotics: compound sulfamethoxazole tablet (SMZ/TMP) + cefaclor

Compound sulfamethoxazole tablet (SMZ/TMP) 25 mg/kg/d p.o. and cefaclor 12.5 mg/kg/d p.o. alternately every 2 weeks, from post-operation day 15 to month 6.