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Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04370145
Enrollment
160
Registered
2020-04-30
Start date
2021-05-01
Completion date
2022-04-01
Last updated
2022-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangitis, Secondary Biliary, Treatment Compliance, Antibodies Drug Specific

Keywords

Cholangitis, biliary atresia, kasai Portoenterostomy, antibiotics, treatment

Brief summary

Application of multi-center, prospective study on the severity of postoperative cholangitis biliary atresia classification, according to the degree of cholangitis targeted therapy, to improve the therapeutic effect of postoperative cholangitis biliary atresia, decrease the overuse of antibiotics related complications.

Detailed description

Cholangitis patients post-kasai Portoenterostomy were grouped by cholangitis severity score, according to the severity was divided into mild, moderate, severe cholangitis, all levels of cholangitis patients were divided into subgroups by age and post-kasai Portoenterostomy jaundice matching design of experiment, then they were randomly divided into control group and experimental group, and all the control group unified antibiotic treatment, the experimental group was graded antibiotic treatment according to the severity cholangitis, after three days treatment,evaluate each treatment effect, average hospitalization days, the average hospitalization expenses, antimicrobial drug use strength to evaluate the therapeutic effect of postoperative cholangitis biliary atresia.

Interventions

DRUGSulperazon

moderate cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.

DRUGTeicoplanin

severe cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.

cholangitis in control group were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.

Sponsors

Shanghai Children's Hospital
CollaboratorOTHER
Tongji Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Cholangitis patients post-kasai Portoenterostomy were grouped by cholangitis severity score, according to the severity was divided into mild, moderate, severe cholangitis, all levels of cholangitis patients were divided into subgroups by age and post-kasai Portoenterostomy jaundice matching design of experiment, then they were randomly divided into control group and experimental group.

Eligibility

Sex/Gender
ALL
Age
3 Months to 2 Years
Healthy volunteers
No

Inclusion criteria

1. Age 3 months to 2 years old, gender is not limited. 2. Patients with cholangitis post-kasai Portoenterostomy. 3. No other treatment before entering the group. 4. The patient must sign an informed consent form and can actively cooperate with the treatment and follow-up.

Exclusion criteria

1. Patients with other infectious lesions. 2. Patients with other severe deformity. 3. Patients with end-stage liver failure. 4. Patientsn with liver transplantation. 5. Patients with mental symptoms or other disease.

Design outcomes

Primary

MeasureTime frameDescription
Recovery rate7 daysThe cure indicator including:1.Temperature:T≤37.5℃; 2. Infection index:WBC\<10x109/L, CRP\<10mg/L. After 7days treatment, we calculate the cure number and recovery rate of each group to evaluate the efficiency.

Secondary

MeasureTime frameDescription
Recurrence rate1 yearTo collect recurrent episode of cholangitis and recurrent rate of each group.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026