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Therapeutic effect of prophylactic intravenous antibiotics after Kasai procedure in biliary atresia

A clinical randomized controlled study to investigate the preventive effect of prophylactic intravenous antibiotics against cholangitis after Kasai procedure in biliary atresia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16008609
Enrollment
Unknown
Registered
2016-06-07
Start date
2016-07-01
Completion date
Unknown
Last updated
2017-06-12

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

Conditions

biliary atresia

Interventions

Short-term Group:Cefoperazone 5 days
Long-term Group:Cefoperazone 14 days

Sponsors

Children's Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. Perform Kasai portoenterostomy for Type 3 Biliary Atresia in Children's Hospital of Fudan University; 2. Post-conception age older than 36 weeks, both genders; 3. No history of drug allergies to the medications used during the trial; 4. No preoperation use of antibiotics or probiotics; 5. Written informed consent to participate in the clinical trial obtained prior to completion of Kasai procedure.

Exclusion criteria

Exclusion criteria: 1. Kasai portoenterostomy performed in other institutions; 2. Known allergy to the medication used during the trial or other adjuvant therapies; 3. Preoperation use of antibiotics or probiotics; 4. With other severe concurrent illnesses that will interfere with the conduct and results of the study.

Design outcomes

Primary

MeasureTime frame
Percentage of cholangitis at 6 months after Kasai procedure;

Secondary

MeasureTime frame
The first occurrence, frequency and duration of cholangitis;Survival with native liver at 6 months after Kasai procedure;Serum total bilirubin concentration and liver function prior and at 1 month, 3 months, 6 months after Kasai procedure;Percentage of cholangitis at 3 months after Kasai procedure;Percentage of jaundice clearance (serum total bilirubin less than 20 umol/L) at 3 months, 6 months after Kasai procedure;Percentage of adverse events at 1, 3, 6 months after Kasai procedure;

Countries

China

Contacts

Public ContactShan Zheng

Children's Hospital of Fudan University

szheng@shmu.edu.cn+86 15900898826

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026