Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

Tongji Hospital160 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Cholangitis, Secondary Biliary Treatment Compliance Antibodies Drug Specific

Interventions

SulperazonDRUG

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

TeicoplaninDRUG

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

Meropenem InjectionDRUG

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

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 2 Years

Medical Language ↔ Plain English

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.

Locations (2)

Tongji hospital affiliated to tongji medical college of huazhong university of science and technology

Wuhan, Hubei, China

TongjiHospital

Wuhan, Hubei, China

Outcomes

Primary Outcomes

Recovery rate

The 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.

Time frame: 7 days

Secondary Outcomes

Recurrence rate

To collect recurrent episode of cholangitis and recurrent rate of each group.

Time frame: 1 year

Data from ClinicalTrials.gov

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