BA - Biliary AtresiaBANCT05917236
Biliary Atresia With Rare Associations, a Case Report
An observational study of BA - Biliary Atresia, run by Sarah Magdy Abdelmohsen at 1 site in Egypt.
Trial summary
Background: It is not often written in medical journals that preduodenal portal vein, biliary atresia, intestinal malrotation, and situs inversus totalis are all related. Case reports: A two-month-old female infant had biliary atresia type III, situs inversus totalis, midgut malrotation, and preduodenal portal vein. Read more about this study
- Who is it for?
- Ages 2 to 3 months, women only
- Conditions the study is for
- BA - Biliary Atresia
- What is being tested?
- hepato-portoentostomy
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 1 Sep 2022
- How long will I take part?
- 1 Year
- 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 2 to 3 months
- Women only
- Child
Study population: one case reports
Who may be able to join
- Biliary atresia with another syndrome
Who cannot join
- Biliary atresia alone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biliary Atresia and Preduodenal Portal Vein
Background: It is not often written in medical journals that preduodenal portal vein, biliary atresia, intestinal malrotation, and situs inversus totalis are all related.
Case reports: A two-month-old female infant had biliary atresia type III, situs inversus totalis, midgut malrotation, and preduodenal portal vein. She had been operated on by the Kasai procedure (hepato-portoenterostomy).
Discussion: It is important to carefully look into the relationship between preduodenal portal vein and biliary atresia because the patient at a risk of injury from this aberrant vein at operative intervention.
Read the detailed description
A full-term female infant, G1P1, weighing 3450 g at birth, was referred to our department at the age of 2 months old with severe jaundice and poor feeding. The mother reported yellow sclera and skin, lightning-colored stool, and dark colored urine a few days after birth, which were progressively aggravated.
On physical examination, the infant had an olive-green colored sclera and skin with an itching mark, a pale clay stool in the diaper, a law grade fever of 37.8°C, a weight of 3870 g, a pulse rate of 138 b/m, and a respiratory rate of 38 b/m. The heart sounds and breath sounds were normal. The abdomen was soft and lax on examination. The liver was two fingers below the costal margin. The intestinal sound was normal.
The laboratory investigation revealed that total bilirubin was elevated at 7 mg/dl, direct bilirubin was elevated at 4 mg/dl, GGT was elevated at 157,1 U/L, alkaline phosphatase was elevated at 279 U/L, and albumin was decreased at 3.4 g/dL.
Abdominal ultrasonography revealed a triangular cord sign in the liver hilum, an absent gall bladder, and a normal-sized spleen on the right side behind the liver. A chest x-ray revealed dextrocardia. The HIDA scan revealed failure of radioisotope excretion in the duodenum . Non-contrast magnetic resonance cholangiopancreatography (MRCP) showed that the common hepatic duct and the common bile duct could not be seen. Preoperative percutaneous liver biopsy reported liver fibrosis, bile ductules proliferation and cholestasis.
An experienced pediatric surgeon obtained the decision for exploratory laparotomy by right subcostal abdominal incision. The spleen is located in the right upper quadrant behind the liver. Extracorporealization of the liver is done . The gall bladder was rudimentary. On further exploration, the principle investigator also found intestinal malrotation (IM) and PDPV. All extrahepatic bile ducts were absent; type III portal atresia. The portal palate was dissected easily and the rudimentary gall bladder was removed.
Widening of the narrow base of the intestinal mesentery, then reconstruction of the retro-colic Roux-en-Y limb of the jejunum, and finally hepato-portoentostomy (Kasai operation) was done . A wedge liver biopsy obtained reported ductular proliferation, hepatic fibrosis, and bile plugs; a feature suggestive of biliary obstruction.
The post-operative follow-up of the patient revealed features of bile drainage in the intestine; the stool returned to its normal brawn color; and the yellow skin color was slightly improved. Total bilirubin was 4 mg/dl and direct bilirubin was 2 mg/dl. The patient was discharged on the tenth post-operative day.
- Conditions
- BA - Biliary Atresia
- Being tested
- hepato-portoentostomy
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepato-portoentostomyProcedure or surgery
Also called (Kasai operation)
the retro-colic Roux-en-Y limb of the jejunum, and finally hepato-portoentostomy (Kasai operation)
What is being measured
The primary outcome is the main question the study is designed to answer.
Is the infant will still a live or he will dies?
Is the infant will continue his life up to one year or he will dies during the follow-up period.
Measured: from 3 weeks to one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Sep 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BA - 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 only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sarah Magdy Abdelmohsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Magdy Abdelmohsen, Aswan University Hospital
- Investigators
- Sarah M Abdelmohsen, Lecturer, Study director, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917236
- Sponsor's protocol ID
- AswanUH4
- Acronym
- BA
- Status last verified
- Jun 2023
- First submitted
- 26 Oct 2022
- Last updated
- 23 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biliary Atresia and Preduodenal Portal Vein
- ClinicalTrials.gov ID
- NCT05917236
- Acronym / sponsor ID
- BA / AswanUH4
- Conditions
- BA - Biliary Atresia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Sarah Magdy AbdelmohsenUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 23 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.
Background: It is not often written in medical journals that preduodenal portal vein, biliary atresia, intestinal malrotation, and situs inversus totalis are all related.
Case reports: A two-month-old female infant had biliary atresia type III, situs inversus totalis, midgut malrotation, and preduodenal portal vein. She had been operated on by the Kasai procedure (hepato-portoenterostomy).
Discussion: It is important to carefully look into the relationship between preduodenal portal vein and biliary atresia because the patient at a risk of injury from this aberrant vein at operative intervention.
Detailed description
A full-term female infant, G1P1, weighing 3450 g at birth, was referred to our department at the age of 2 months old with severe jaundice and poor feeding. The mother reported yellow sclera and skin, lightning-colored stool, and dark colored urine a few days after birth, which were progressively aggravated.
On physical examination, the infant had an olive-green colored sclera and skin with an itching mark, a pale clay stool in the diaper, a law grade fever of 37.8°C, a weight of 3870 g, a pulse rate of 138 b/m, and a respiratory rate of 38 b/m. The heart sounds and breath sounds were normal. The abdomen was soft and lax on examination. The liver was two fingers below the costal margin. The intestinal sound was normal.
The laboratory investigation revealed that total bilirubin was elevated at 7 mg/dl, direct bilirubin was elevated at 4 mg/dl, GGT was elevated at 157,1 U/L, alkaline phosphatase was elevated at 279 U/L, and albumin was decreased at 3.4 g/dL.
Abdominal ultrasonography revealed a triangular cord sign in the liver hilum, an absent gall bladder, and a normal-sized spleen on the right side behind the liver. A chest x-ray revealed dextrocardia. The HIDA scan revealed failure of radioisotope excretion in the duodenum . Non-contrast magnetic resonance cholangiopancreatography (MRCP) showed that the common hepatic duct and the common bile duct could not be seen. Preoperative percutaneous liver biopsy reported liver fibrosis, bile ductules proliferation and cholestasis.
An experienced pediatric surgeon obtained the decision for exploratory laparotomy by right subcostal abdominal incision. The spleen is located in the right upper quadrant behind the liver. Extracorporealization of the liver is done . The gall bladder was rudimentary. On further exploration, the principle investigator also found intestinal malrotation (IM) and PDPV. All extrahepatic bile ducts were absent; type III portal atresia. The portal palate was dissected easily and the rudimentary gall bladder was removed.
Widening of the narrow base of the intestinal mesentery, then reconstruction of the retro-colic Roux-en-Y limb of the jejunum, and finally hepato-portoentostomy (Kasai operation) was done . A wedge liver biopsy obtained reported ductular proliferation, hepatic fibrosis, and bile plugs; a feature suggestive of biliary obstruction.
The post-operative follow-up of the patient revealed features of bile drainage in the intestine; the stool returned to its normal brawn color; and the yellow skin color was slightly improved. Total bilirubin was 4 mg/dl and direct bilirubin was 2 mg/dl. The patient was discharged on the tenth post-operative day.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 2 to 3 months
- Sex
- Female only
- Age groups
- Child
- Study population
- one case reports
Key inclusion criteria (1 listed)
- Biliary atresia with another syndrome
Key exclusion criteria (1 listed)
- Biliary atresia alone
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 |
|---|---|---|
| hepato-portoentostomyAlso: (Kasai operation)the retro-colic Roux-en-Y limb of the jejunum, and finally hepato-portoentostomy (Kasai operation) | Procedure or surgery | – |
Primary outcome
Is the infant will still a live or he will dies?
Time frame: from 3 weeks to one year follow up
Is the infant will continue his life up to one year or he will dies during the follow-up period.
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 23 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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 M Abdelmohsen, Lecturer study director
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 BA - Biliary Atresia, run by Sarah Magdy Abdelmohsen 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 23 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?
Is the infant will still a live or he will dies? (time frame: from 3 weeks to one year follow up). 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 23 Jun 2023.