NCT04961034

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

6.4 years

First QC Date

July 9, 2021

Last Update Submit

April 26, 2022

Conditions

Biliary Atresia

Keywords

biliary atresiakasai portoenterostomymodifiedcholangitis

Outcome Measures

Primary Outcomes (2)

  • the total number of cholangitis

    the total attacks of chollangitis

    two years

  • number of native liver survivors

    the decrease of the need of liver transplantation in children with biliary atresia

    two years

Secondary Outcomes (1)

  • early improvement of liver functions

    6 months

Study Arms (2)

classic KPE

OTHER

the classic management of biliary atresia as described

Procedure: kasai portoenterostomy

modified KPE

OTHER

we added 2 sutures posterior, one on each side and two anterior. this will hang the jejunal loop to promote tension free anastomosis

Procedure: kasai portoenterostomy

Interventions

kasai portoenterostomyPROCEDURE

surgical creation of stoma between porta hepatis and jejunal loop

classic KPEmodified KPE

Eligibility Criteria

Age4 Weeks - 8 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • infants with biliary atresia diagnosed and treated before 60th day of age

You may not qualify if:

  • infants older than 60 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tanta University

Tanta, Gharbia Governorate, 31111, Egypt

COMPLETED

Tantra Universiy

Tanta, 31512, Egypt

RECRUITING

MeSH Terms

Conditions

Biliary AtresiaCholangitis

Interventions

Portoenterostomy, Hepatic

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesDigestive System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeBiliary Tract Surgical ProceduresDigestive System Surgical Procedures

Central Study Contacts

Mohammad Khirallah

CONTACT

+201003546853mohamed.khirallah@med.tanta.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of pediatric surgery

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 14, 2021

Study Start

January 1, 2015

Primary Completion

June 1, 2021

Study Completion

December 20, 2023

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

publication as article

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
6 months

Locations

EG(2)