Biliary AtresiaNCT05925543
Outcome of Kasai Portoenterostomy in Biliary Atresia in Upper Egypt
An observational study of Biliary Atresia, run by Aswan University Hospital at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 4 to 19 weeks
- Conditions the study is for
- Biliary Atresia
- What is being tested?
- Kasai portoenterostomy operation.
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 19 weeks
- All sexes
- Child
Study population: all neonates diagnosed with biliary atresia in the previous period (2019) and managed by Kasai portoenterostomy.
Who may be able to join
- all neonates diagnosed with biliary atresia in the previous period and managed by Kasai portoenterostomy.
Who cannot join
- Exclusion criteria were neonates without a confirmed diagnosis of biliary atresia.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Biliary Atresia
- Being tested
- Kasai portoenterostomy operation.
- Keywords
- Cholestasis, Neonate jaundice, Cholangitis, Short-term outcome, Survival with the native liver
- Medical subject headings
- Biliary Atresia, Cholestasis, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kasai portoenterostomy operation.Procedure or surgery
Also called Kasai operation
Kasai portoenterostomy operation for biliary atresia patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Kasai portoenterostomy operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from 3 months up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Jan 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary AtresiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Magdy Abdelmohsen, Aswan University Hospital
- Investigators
- Sarah Abdelmohsen, Md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925543
- Sponsor's protocol ID
- Aswan UH7
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Kasai Portoenterostomy in Biliary Atresia in Upper Egypt
- ClinicalTrials.gov ID
- NCT05925543
- Acronym / sponsor ID
- Aswan UH7
- Conditions
- Biliary Atresia
- Keywords
- Cholestasis, Neonate jaundice, Cholangitis, Short-term outcome, Survival with the native liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all neonates diagnosed with biliary atresia and managed by Kasai portoenterostomy. | – | Procedure: Kasai portoenterostomy operation.all neonates diagnosed with biliary atresia in the previous period 2019 and managed by Kasai portoenterostomy. |
Who may qualify
- Ages
- 4 to 19 weeks
- Sex
- All
- Age groups
- Child
- Study population
- all neonates diagnosed with biliary atresia in the previous period (2019) and managed by Kasai portoenterostomy.
Key inclusion criteria (1 listed)
- all neonates diagnosed with biliary atresia in the previous period and managed by Kasai portoenterostomy.
Key exclusion criteria (1 listed)
- Exclusion criteria were neonates without a confirmed diagnosis of biliary atresia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kasai portoenterostomy operation.Also: Kasai operationKasai portoenterostomy operation for biliary atresia patients. | Procedure or surgery | all neonates diagnosed with biliary atresia and managed by Kasai portoenterostomy. |
Primary outcome
the rate of jaundice clearance
Time frame: from 3 months up to one year
the clearance of jaundice measured by total serum bilirubin < 1.2 mg \ dL and direct bilirubin < 0.3 mg dL within one year postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Abdelmohsen, Md principal investigator
Aswan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Atresia, run by Aswan University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of jaundice clearance (time frame: from 3 months up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.