Clinical trial NCT04370145: Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy
Official title: Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholangitis, Secondary Biliary
Treatment Compliance
Antibodies Drug Specific
Keywords: Cholangitis
biliary atresia
kasai Portoenterostomy
antibiotics
treatment
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Children's Hospital
First posted: 2020-04-30
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recovery rate
timeFrame: 7 days
Secondary outcomes:
measure: Recurrence rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji hospital affiliated to tongji medical college of huazhong university of science and technology
state: Hubei
city: Wuhan
country: China
facility: TongjiHospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Feng Jiexiong, Postdoctoral
role: PRINCIPAL_INVESTIGATOR
References: