Biliary AtresiaNCT02471209
Biliary Atresia, Hepatic Buffer Response and Sevoflurane
An observational study of Biliary Atresia, run by Children's Hospital of Fudan University.
Trial summary
To evaluate the effects of sevoflurane on hepatic blood flow (HBF) and hepatic arterial buffer response (HABR) in infants with obstructive jaundice by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were enrolled. Read more about this study
- Who is it for?
- Ages 1 month to 3 months
- Conditions the study is for
- Biliary Atresia
- What is being tested?
- Sevoflurane
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Feb 2014
- 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 1 month to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: infants with biliary atresia scheduled for a Kasai procedure
Who may be able to join
- persistent yellow skin or sclera, pale stool (in severe cases, clay-like), and hepatomegaly;
- increased serum bilirubin (progressively or no decline after increase), increased total bilirubin (TBil) dominated by increased direct bilirubin (DBil) (>60%);
- elevated liver enzymes;
- ultrasound confirmation of poor gallbladder filling and signs of liver fibrosis;
- with radionuclide imaging confirmation of obstructed biliary excretion
Who cannot join
- concomitant cardiovascular or abdominal organ malformations
About this study
To evaluate the effects of sevoflurane on hepatic blood flow (HBF) and hepatic arterial buffer response (HABR) in infants with obstructive jaundice by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were enrolled. portal vein blood flow (PBF), hepatic arterial blood flow (HABF) and hepatic blood flow (HBF) were measured by Doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.
Read the detailed description
Children suffering from hepatobiliary disease also have an hepatic arterial buffer response (HABR) with reduced portal vein blood flow (PBF) and compensatory increases in hepatic arterial blood flow (HABF) which can help maintain hepatic blood flow (HBF). For infants with obstructive hepatobiliary disease, reduced HBF may affect drug metabolism and increase the risk of respiratory depression during analgesia, which can be life-threatening.
To evaluate the effects of sevoflurane on HBF and HABR in infants with obstructive jaundice by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were enrolled. PBF, HABF and HBF were measured by Doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.
- Conditions
- Biliary Atresia
- Being tested
- Sevoflurane
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called general anesthesia
general anesthesia with 2% followed by 3% sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Biliary Atresia Infants | Twenty-five infants diagnosed with Biliary Atresia and undergoing surgery were included in the study (age range 1-3 months). Inclusion criteria were persistent yellow skin or sclera, pale stool (in severe cases, clay-like), and hepatomegaly; increased serum bilirubin (progressively or no decline after increase), increased total bilirubin (TBil) dominated by increased direct bilirubin (DBil) (>60%); elevated liver enzymes; ultrasound confirmation of poor gallbladder filling and signs of liver fibrosis; with radionuclide imaging confirmation of obstructed biliary excretion. Infants were excluded if they had concomitant cardiovascular or abdominal organ malformations. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
portal blood flow
Measured: 10 minutes
hepatic arterial blood flow
Measured: 10 minutes
hepatic blood flow
Measured: 10 minutes
Secondary outcomes (3)
blood pressure
noninvasive blood pressure
Measured: 5 minutes
renal blood flow
Measured: 10 minutes
femoral vein blood flow
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionFeb 2014
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 only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471209
- Sponsor's protocol ID
- mzk-0003-2011
- Status last verified
- Jun 2015
- First submitted
- 3 Jun 2015
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biliary Atresia, Hepatic Buffer Response and Sevoflurane
- ClinicalTrials.gov ID
- NCT02471209
- Acronym / sponsor ID
- mzk-0003-2011
- Conditions
- Biliary Atresia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Jun 2015 (estimated)
- 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.
To evaluate the effects of sevoflurane on hepatic blood flow (HBF) and hepatic arterial buffer response (HABR) in infants with obstructive jaundice by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were enrolled. portal vein blood flow (PBF), hepatic arterial blood flow (HABF) and hepatic blood flow (HBF) were measured by Doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.
Detailed description
Children suffering from hepatobiliary disease also have an hepatic arterial buffer response (HABR) with reduced portal vein blood flow (PBF) and compensatory increases in hepatic arterial blood flow (HABF) which can help maintain hepatic blood flow (HBF). For infants with obstructive hepatobiliary disease, reduced HBF may affect drug metabolism and increase the risk of respiratory depression during analgesia, which can be life-threatening.
To evaluate the effects of sevoflurane on HBF and HABR in infants with obstructive jaundice by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were enrolled. PBF, HABF and HBF were measured by Doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biliary Atresia Infants | – | Drug: SevofluraneTwenty-five infants diagnosed with Biliary Atresia and undergoing surgery were included in the study (age range 1-3 months). Inclusion criteria were persistent yellow skin or sclera, pale stool (in severe cases, clay-like), and hepatomegaly; increased serum bilirubin (progressively or no decline after increase), increased total bilirubin (TBil) dominated by increased direct bilirubin (DBil) (>60%); elevated liver enzymes; ultrasound confirmation of poor gallbladder filling and signs of liver fibrosis; with radionuclide imaging confirmation of obstructed biliary excretion. Infants were excluded if they had concomitant cardiovascular or abdominal organ malformations. |
Who may qualify
- Ages
- 1 month to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infants with biliary atresia scheduled for a Kasai procedure
Key inclusion criteria (5 listed)
- persistent yellow skin or sclera, pale stool (in severe cases, clay-like), and hepatomegaly;
- increased serum bilirubin (progressively or no decline after increase), increased total bilirubin (TBil) dominated by increased direct bilirubin (DBil) (>60%);
- elevated liver enzymes;
- ultrasound confirmation of poor gallbladder filling and signs of liver fibrosis;
- with radionuclide imaging confirmation of obstructed biliary excretion
Key exclusion criteria (1 listed)
- concomitant cardiovascular or abdominal organ malformations
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 |
|---|---|---|
| SevofluraneAlso: general anesthesiageneral anesthesia with 2% followed by 3% sevoflurane | Drug | Biliary Atresia Infants |
Primary outcome
portal blood flow
Time frame: 10 minutes
hepatic arterial blood flow
Time frame: 10 minutes
hepatic blood flow
Time frame: 10 minutes
3 secondary outcomes
blood pressure
Time frame: 5 minutes
renal blood flow
Time frame: 10 minutes
femoral vein blood flow
Time frame: 10 minutes
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 15 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Atresia, run by Children's Hospital of Fudan University.
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 5 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 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
portal blood flow (time frame: 10 minutes). The study lists 3 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 15 Jun 2015; AzTrials last refreshed its copy on 30 Oct 2026.