Biliary AtresiaNCT04961034
Peri Kasai Portoenterostomy Anchoring of the Jejunal Loop
A study testing kasai portoenterostomy in people with Biliary Atresia, run by Tanta University at 2 sites in Egypt.
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 Read more about this study
- Who is it for?
- Ages 4 to 8 weeks
- Conditions the study is for
- Biliary Atresia
- What is being tested?
- kasai portoenterostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesEgypt
- Study dates
- Jan 2015to 20 Dec 2023
- Phase
- Interventional
- 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 8 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants with biliary atresia diagnosed and treated before 60th day of age
Who cannot join
- infants older than 60 days
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 1 recruiting
- Completed
Tanta University
Tanta, Gharbia Governorate, 31111
- Recruiting
Tantra Universiy
Tanta, 31512
Mohammad Khirallah, +201003546853, mohamed.khirallah@med.tanta.edu.eg
About this study
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
Read the detailed 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.
- Conditions
- Biliary Atresia
- Being tested
- kasai portoenterostomy
- Keywords
- biliary atresia, kasai portoenterostomy, modified, cholangitis
- Medical subject headings
- Biliary Atresia, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kasai portoenterostomyProcedure or surgery
surgical creation of stoma between porta hepatis and jejunal loop
| Study group | Role | What they receive |
|---|---|---|
| classic KPE | Other | the classic management of biliary atresia as described Receives: 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 Receives: Procedure: kasai portoenterostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the total number of cholangitis
the total attacks of chollangitis
Measured: two years
number of native liver survivors
the decrease of the need of liver transplantation in children with biliary atresia
Measured: two years
Secondary outcomes (1)
early improvement of liver functions
normalization of liver function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study startJan 2015
- Primary completionJun 2021
- Study completion20 Dec 2023 (estimated)
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.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Gharieb Mohammad Khirallah, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961034
- Sponsor's protocol ID
- 33943/7/20
- Status last verified
- Apr 2022
- First submitted
- 9 Jul 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: publication as article
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri Kasai Portoenterostomy Anchoring of the Jejunal Loop
- ClinicalTrials.gov ID
- NCT04961034
- Acronym / sponsor ID
- 33943/7/20
- Conditions
- Biliary Atresia
- Keywords
- biliary atresia, kasai portoenterostomy, modified, cholangitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 14 Jul 2021 (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.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classic KPE | Other | Procedure: kasai portoenterostomythe classic management of biliary atresia as described |
| modified KPE | Other | Procedure: kasai portoenterostomywe added 2 sutures posterior, one on each side and two anterior. this will hang the jejunal loop to promote tension free anastomosis |
Who may qualify
- Ages
- 4 to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants with biliary atresia diagnosed and treated before 60th day of age
Key exclusion criteria (1 listed)
- infants older than 60 days
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 portoenterostomysurgical creation of stoma between porta hepatis and jejunal loop | Procedure or surgery | classic KPE, modified KPE |
Primary outcome
the total number of cholangitis
Time frame: two years
the total attacks of chollangitis
number of native liver survivors
Time frame: two years
the decrease of the need of liver transplantation in children with biliary atresia
1 secondary outcome
early improvement of liver functions
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: Yes. publication as article
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kasai portoenterostomy in people with Biliary Atresia, run by Tanta University at 2 sites 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: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Khirallah (+201003546853, mohamed.khirallah@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the total number of cholangitis (time frame: two years). The study lists 2 primary outcomes in all. 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 27 Apr 2022.