Biliary AtresiaNCT05909033
Early Predictors for the Short Term Native Liver Survival in Patients With Biliary Atresia After Kasai Procedure
An observational study of Biliary Atresia, run by Weibing Tang at 1 site in China.
Trial summary
Many factors have been proven that may affect NLS in BA patients after KP;however,the early predictors for NLS were not be finally detected.This study was designed to evaluate and identify the preoperative and early postoperative factors associated with NLS for early prediction in BA patients after KP. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Biliary Atresia
- What is being tested?
- Kasai procedure
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2017to 1 Jul 2023
- 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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: patients with Biliary atreisa and were performed with kasai procedures
Who may be able to join
- Biliary Atresia(BA) patients performed with Kasai Procedure patients completed the follow-up>6 months
Who cannot join
- BA patients without KP patients lost of follow-up BA patients with other severe complications lead to death
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Nanjing Medical University
Nanjing, 210008
Changgui Lu, Dr, luchanggui1984@163.com
About this study
Many factors have been proven that may affect NLS in BA patients after KP;however,the early predictors for NLS were not be finally detected.This study was designed to evaluate and identify the preoperative and early postoperative factors associated with NLS for early prediction in BA patients after KP.
Read the detailed description
Biliary atresia (BA) is the most common cause of neonatal cholestasis, occurring in approximately 1: 8000 to 1:15000 in Asian populations compared with those in Europe and the USA, with a ratio of 1: 1.56 in males and females.Until now, Kasai procedure(KP) remains the preferred treatment for biliary BA;however,nearly 60-70% patients after KP need liver transplants to achieve long-term survival.Therefore, it is meaningful to seek and analyze the factors affecting the native liver survival(NLS) in BA patients with KP for prediction. Luckily， A lot of studies have designed to seek the risk factors for death or liver transplants in BA patients after KP,and many factors have been proven that may affect NLS,including old age at KP,low gamma-glutamyl transpeptidase(GGT) level,Cytomegalovirus(CMV) Infection,early jaundice clearance(JC) and postoperative cholangitis(PC),etal.However,the predictors for NLS were not be finally detected.Otherwise,the safety of liver transplants has been improved in the past few years and performing liver transplant in young infants has been proven to be feasible.Then,it is important to seek early NLS predictors for counseling the necessity and timing of liver transplant.Unfortunately,early predictors of NLS focus on preoperative and early postoperative period after KP were insufficient.
This study is primarily designed to evaluate and identify the preoperative and early postoperative factors associated with NLS for early prediction in BA patients after KP.
- Conditions
- Biliary Atresia
- Being tested
- Kasai procedure
- Keywords
- biliary Atresia, Kasai procedure, early predictor, native liver survival
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kasai procedureProcedure or surgery
All KPs were performed by a medical team. This technique involved creation of a 35-40 cm Roux loop to facilitate biliary drainage. After dissection of the hepatic vasculature at the hilum and excision of the hilar plate, hepaticojejunostomy was performed as an anastomosis extending from the bifurcation of the right hepatic artery into anterior and posterior branches to the Rex confluence of the left portal vein with the obliterated umbilical vein.
What is being measured
The primary outcome is the main question the study is designed to answer.
NLS rate
native liver survival rate
Measured: through study completion, an average of 3 years
Secondary outcomes (3)
age at KP
age at kasai procedure
Measured: through study completion, an average of 3 years
PC
post cholangitis
Measured: through study completion, an average of 3 years
JC
jaudiance clearance
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start20 May 2017
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weibing Tang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weibing Tang, Nanjing Children's Hospital
- Investigators
- Weibing Tang, Dr, Study director, Children's Hospital of Nanjing Medical UniversityWeibing Tang, Dr, Principal investigator, Children's Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909033
- Sponsor's protocol ID
- NanjingCH20230601
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
Lu C, Xie H, Zhu Z, Ding Z, Geng Q, Tang W. A convenient nomogram for predicting early death or liver transplantation after the Kasai procedure in patients with biliary atresia. Langenbecks Arch Surg. 2024 Jan 8;409(1):30. doi: 10.1007/s00423-023-03216-5.
PubMed 38189999
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Predictors for the Short Term Native Liver Survival in Patients With Biliary Atresia After Kasai Procedure
- ClinicalTrials.gov ID
- NCT05909033
- Acronym / sponsor ID
- NanjingCH20230601
- Conditions
- Biliary Atresia
- Keywords
- biliary Atresia, Kasai procedure, early predictor, native liver survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Weibing TangUniversity, hospital or other
- Study start
- 20 May 2017 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 18 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.
Many factors have been proven that may affect NLS in BA patients after KP;however,the early predictors for NLS were not be finally detected.This study was designed to evaluate and identify the preoperative and early postoperative factors associated with NLS for early prediction in BA patients after KP.
Detailed description
Biliary atresia (BA) is the most common cause of neonatal cholestasis, occurring in approximately 1: 8000 to 1:15000 in Asian populations compared with those in Europe and the USA, with a ratio of 1: 1.56 in males and females.Until now, Kasai procedure(KP) remains the preferred treatment for biliary BA;however,nearly 60-70% patients after KP need liver transplants to achieve long-term survival.Therefore, it is meaningful to seek and analyze the factors affecting the native liver survival(NLS) in BA patients with KP for prediction. Luckily， A lot of studies have designed to seek the risk factors for death or liver transplants in BA patients after KP,and many factors have been proven that may affect NLS,including old age at KP,low gamma-glutamyl transpeptidase(GGT) level,Cytomegalovirus(CMV) Infection,early jaundice clearance(JC) and postoperative cholangitis(PC),etal.However,the predictors for NLS were not be finally detected.Otherwise,the safety of liver transplants has been improved in the past few years and performing liver transplant in young infants has been proven to be feasible.Then,it is important to seek early NLS predictors for counseling the necessity and timing of liver transplant.Unfortunately,early predictors of NLS focus on preoperative and early postoperative period after KP were insufficient.
This study is primarily designed to evaluate and identify the preoperative and early postoperative factors associated with NLS for early prediction in BA patients after KP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients with Biliary atreisa and were performed with kasai procedures
Key inclusion criteria (1 listed)
- Biliary Atresia(BA) patients performed with Kasai Procedure patients completed the follow-up>6 months
Key exclusion criteria (1 listed)
- BA patients without KP patients lost of follow-up BA patients with other severe complications lead to death
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 procedureAll KPs were performed by a medical team. This technique involved creation of a 35-40 cm Roux loop to facilitate biliary drainage. After dissection of the hepatic vasculature at the hilum and excision of the hilar plate, hepaticojejunostomy was performed as an anastomosis extending from the bifurcation of the right hepatic artery into anterior and posterior branches to the Rex confluence of the left portal vein with the obliterated umbilical vein. | Procedure or surgery | – |
Primary outcome
NLS rate
Time frame: through study completion, an average of 3 years
native liver survival rate
3 secondary outcomes
age at KP
Time frame: through study completion, an average of 3 years
PC
Time frame: through study completion, an average of 3 years
JC
Time frame: through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 38189999Lu C, Xie H, Zhu Z, Ding Z, Geng Q, Tang W. A convenient nomogram for predicting early death or liver transplantation after the Kasai procedure in patients with biliary atresia. Langenbecks Arch Surg. 2024 Jan 8;409(1):30. doi: 10.1007/s00423-023-03216-5.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
Weibing Tang, Dr study director
Children's Hospital of Nanjing Medical University
Weibing Tang, Dr principal investigator
Children's Hospital of Nanjing Medical University
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 Weibing Tang at 1 site in China.
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 18 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 China. 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 Changgui Lu, Dr (13770848448, luchanggui1984@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NLS rate (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05909033, which also lists 1 linked publication.
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 18 Jun 2023.