Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy

NARecruitingINTERVENTIONAL
Enrollment

356

Participants

Timeline

Start Date

July 1, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

July 31, 2027

Conditions
Biliary AtresiaCholangitisAnti-Bacterial Agents
Interventions
DRUG

Basic 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.

DRUG

Prophylactic 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.

Trial Locations (1)

201102

RECRUITING

Children's Hospital of Fudan University, Shanghai

All Listed Sponsors
lead

Children's Hospital of Fudan University

OTHER