NCT05925543

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

12 months

First QC Date

June 22, 2023

Last Update Submit

June 22, 2023

Conditions

Biliary Atresia

Keywords

CholestasisNeonate jaundiceCholangitisShort-term outcomeSurvival with the native liver

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

all neonates diagnosed with biliary atresia and managed by Kasai portoenterostomy.

all neonates diagnosed with biliary atresia in the previous period 2019 and managed by Kasai portoenterostomy.

Procedure: Kasai portoenterostomy operation.

Interventions

Kasai portoenterostomy operation.PROCEDURE

Kasai portoenterostomy operation for biliary atresia patients.

Also known as: Kasai operation
all neonates diagnosed with biliary atresia and managed by Kasai portoenterostomy.

Eligibility Criteria

Age4 Weeks - 19 Weeks
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

all neonates diagnosed with biliary atresia in the previous period (2019) and managed by Kasai portoenterostomy.

You may qualify if:

  • all neonates diagnosed with biliary atresia in the previous period and managed by Kasai portoenterostomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan university Hospital

Aswān, Aswan Governorate, 11331, Egypt

Location

MeSH Terms

Conditions

Biliary AtresiaCholestasisCholangitis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sarah Abdelmohsen, Md

    Aswan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 22, 2023

First Posted

June 29, 2023

Study Start

January 1, 2019

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

It was a cross-sectional retrospective multicenter study from Upper Egypt. The data will collect from the medical records of three university hospitals in Upper Egypt from January 2019 to December 2019.

Shared Documents
STUDY PROTOCOL
Time Frame
January 2019- December 2019
Access Criteria
Biliary Atresia in Upper Egypt

Locations

EG(1)