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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem
DrugSulperazone 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.
Prophylactic oral antibiotics: compound sulfamethoxazole tablet (SMZ/TMP) + cefaclor
DrugCompound 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.
Treatment groups
356 Participants
are divided into 2 treatment groupsGroup A: Antibiotics groupActive comparator 2 interventions
Group B: Non-antibiotics groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The occurrence of cholangitis (confirmed or suspected) within 6 months after KP
Definition of cholangitis: A. Clinical elements 1. Fever and/or shivering; 2. Stool color change; 3. New/increasing jaundice; 4. Abdominal discomfort: vomiting, poor, feeding, irritability. B. Laboratory and imaging elements 1. Inflammatory response (WBC and/or CRP and/or PCT); 2. Increased/increasing transaminases; 3. Increased/increasing GGT and/or bilirubin; 4. Bile lakes. Suspected cholangitis: one item in A + one item in B. Confirmed cholangitis: two items in A + two items in B or "suspected cholangitis" + positive blood culture. The diagnosis of cholangitis requires the exclusion of definite infections of other systems.
Time frame
6 months after KPSecondary outcomes
1
The occurrence of cholangitis (confirmed or suspected) within 1 year after KP
The definition of cholangitis is the same as primary outcome.
Time frame
1 year after KP2
The occurrence of jaundice clearance within 6 months after KP
Jaundice clearance is defined as total bilirubin (TB) less than 20 μmol/L.
Time frame
6 months after KP3
The occurrence of jaundice clearance within 1 year after KP
Jaundice clearance is defined as TB less than 20 μmol/L.
Time frame
1 year after KP4
The number of cholangitis recurrence within 6 months after KP
The definition of cholangitis is the same as primary outcome.
Time frame
6 months after KPSponsors and contacts
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Source ClinicalTrials.gov