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NCT05925543 Clinical Trial

Outcome of Kasai Portoenterostomy in Biliary Atresia in Upper Egypt

Biliary Atresia Clinical Trial

Official title:
Outcome of Kasai Portoenterostomy in Biliary Atresia in Upper Egypt

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05925543
Other study ID # Aswan UH7
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 30, 2019

Study information
Verified date June 2023
Source Aswan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Kasai portoenterostomy is the key standard operation for biliary atresia. The aim of the study is to evaluate the short-term outcome of Kasai portoenterostomy for biliary atresia infants in Upper Egypt.

Description:

It is a cross-sectional retrospective multicenter study from Upper Egypt. The data will collected from the medical records of three university hospitals in Upper Egypt from January 2019 to December 2019. Inclusion and exclusion criteria Inclusion criteria included all neonates diagnosed with biliary atresia in the previous period and managed by Kasai portoenterostomy. Exclusion criteria were neonates without a confirmed diagnosis of biliary atresia.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date December 30, 2019
Est. primary completion date December 30, 2019
Accepts healthy volunteers
Gender All
Age group 4 Weeks to 19 Weeks
Eligibility Inclusion Criteria: - all neonates diagnosed with biliary atresia in the previous period and managed by Kasai portoenterostomy. Exclusion Criteria: - Exclusion criteria were neonates without a confirmed diagnosis of biliary atresia.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Kasai portoenterostomy operation.
Kasai portoenterostomy operation for biliary atresia patients.

Locations
Country Name City State
Egypt Aswan university Hospital Aswan Aswan Governorate

Sponsors (1)
Lead Sponsor Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary the rate of jaundice clearance the clearance of jaundice measured by total serum bilirubin < 1.2 mg \ dL and direct bilirubin < 0.3 mg dL within one year postoperatively from 3 months up to one year
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Recruiting NCT05909033 - Early Predictors for the Short Term Native Liver Survival in Patients With Biliary Atresia After Kasai Procedure
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