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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04961034
Other study ID # 33943/7/20
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date December 20, 2023

Study information

Verified date April 2022
Source Tanta University
Contact Mohammad Khirallah
Phone +201003546853
Email mohamed.khirallah@med.tanta.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the study of the effect o the hanging of the jejunal loop to the peri KPE Glisson capsule on the rate of bile drainage and requirement of liver transplantation


Description:

To evaluate the effect of anchoring jejunal loop to Glisson capsule of liver after completion of modified Kasai portoenterostomy (KPE) on the frequency of attacks of cholangitis and the overall incidence of native liver survival. Methods: Retrospective study included 29 infants diagnosed as biliary atresia (BA). They were subjected to modified KPE. Two subgroups were present. Group A included 16 infants and had KPE. Group B included 13 infants and had the assumed modification. Wider dissection of fibrous portal plate was considered in both groups. After completion of KPE, the jejunal loop anchored to Glisson capsule of liver at porta hepatis in group B.


Recruitment information / eligibility

Status Recruiting
Enrollment 26
Est. completion date December 20, 2023
Est. primary completion date June 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 8 Weeks
Eligibility Inclusion Criteria: - infants with biliary atresia diagnosed and treated before 60th day of age Exclusion Criteria: - infants older than 60 days

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
kasai portoenterostomy
surgical creation of stoma between porta hepatis and jejunal loop

Locations

Country Name City State
Egypt Tanta University Tanta Gharbeya
Egypt Tantra Universiy Tanta

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary the total number of cholangitis the total attacks of chollangitis two years
Primary number of native liver survivors the decrease of the need of liver transplantation in children with biliary atresia two years
Secondary early improvement of liver functions normalization of liver function 6 months
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