Peri Kasai Portoenterostomy Anchoring of the Jejunal Loop

Biliary Atresia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04961034
• Other study ID #: 33943/7/20
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Biliary Atresia

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