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CompletedNCT05925543Updated Jun 29, 2023

Outcome of Kasai Portoenterostomy in Biliary Atresia in Upper Egypt

An observational study in Biliary Atresia, sponsored by Aswan University Hospital. Completed at 1 site in Egypt. Open to participants aged 4 Weeks to 19 Weeks. Per ClinicalTrials.gov, last updated 2023-06-29.

Sponsored by Aswan University Hospital · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Retrospective
Enrollment
45
Ages
4 Weeks to 19 Weeks
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Biliary Atresia

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Keywords

  • Cholestasis
  • Neonate jaundice
  • Cholangitis
  • Short-term outcome
  • Survival with the native liver
03

In context

Biliary Atresia

75 studies on the registry are indexed under Biliary Atresia; 25 are open to participants now.

This study's enrollment of 45 is below the median of 126 across 31 observational studies indexed under Biliary Atresia.

Browse Biliary Atresia studies →

Lead sponsor

Aswan University Hospital is the lead sponsor of 95 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Weeks to 19 Weeks
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Exclusion criteria were neonates without a confirmed diagnosis of biliary atresia.
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Study design

Observational model
Case-crossover
Time perspective
Retrospective
Enrollment
45 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureKasai portoenterostomy operation.

    Kasai portoenterostomy operation for biliary atresia patients.

    Also known as: Kasai operation

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What researchers measure

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

    Time frame: from 3 months up to one year

07

Study locations

1 site
  • Aswan university Hospital
    Aswan, Aswan Governorate 11331, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05925543
Lead sponsor
Aswan University Hospital
Responsible party
Sarah Magdy Abdelmohsen (Lecturer, Aswan University Hospital) — Principal investigator
First posted
Jun 29, 2023
Start date
Jan 1, 2019
Primary completion
Dec 30, 2019
Completion
Dec 30, 2019
Last update
Jun 29, 2023

Study contacts

Sarah Abdelmohsen, Md
principal investigator · Aswan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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