Kasai OperationNCT01443572
The Comparison of Desflurane and Sevoflurane on Postoperative Recovery and Hepatic Function of Biliary Atresia Patients During Kasai Operation
A study testing desflurane anesthetics and sevoflurane anesthetics in people with Kasai Operation and Biliary Atresia, run by Yonsei University at 1 site in South Korea.
Trial summary
Biliary atresia (BA) is a perinatal disease of unclear etiology, characterized by inflammation and obliteration of intrahepatic and extrahepatic bile ducts, leading to cholestasis and cirrhosis. Kasai operation remains as the first line operative treatment in BA. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Kasai Operation, Biliary Atresia
- What is being tested?
- desflurane anesthetics and sevoflurane anesthetics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Jul 2014
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients with biliary atresia undergoing Kasai operation
Who cannot join
- patients with congenital anomalies at major organs
Trial locations and contacts
1 site in 1 country.
About this study
Biliary atresia (BA) is a perinatal disease of unclear etiology, characterized by inflammation and obliteration of intrahepatic and extrahepatic bile ducts, leading to cholestasis and cirrhosis. Kasai operation remains as the first line operative treatment in BA. In the previous studies, inhalation anesthetics might induce liver damage. The choice of inhalation anesthetic that minimally affects hepatic function is important. Therefore, the purpose of this study is to compare the postoperative recovery and hepatic function between desflurane and sevoflurane, two most frequently used inhalational anesthetics in patients undergoing Kasai operation.
- Conditions
- Kasai Operation, Biliary Atresia
- Being tested
- desflurane anesthetics, sevoflurane anesthetics
- Keywords
- Kasai operation under general anesthesia
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desflurane anestheticsDrug
40 patients are randomly allocated into two groups : desflurane group (n=20) and sevoflurane group (n=20). And anesthesia is maintained with desflurane (desflurane group) or sevoflurane (sevoflurane group).
sevoflurane anestheticsDrug
40 patients are randomly allocated into two groups : desflurane group (n=20) and sevoflurane group (n=20). And anesthesia is maintained with desflurane (desflurane group) or sevoflurane (sevoflurane group).
| Study group | Role | What they receive |
|---|---|---|
| desflurane group | Experimental | Not described Receives: Drug: desflurane anesthetics |
| sevoflurane group | Active comparator | Not described Receives: Drug: sevoflurane anesthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postoperative recovery
Complete blood count(CBC), prothrombin time(PT), activated partial thromboplastin time(APTT), aspartate aminotransferase(AST), alanine aminotransferase(ALT), alkaline phosphatase(ALP), albumin, total bilirubin, direct bilirubin, gamma-GTP, BUN, creatinine(Cr), electrolyte
Measured: after operation, and on the 1st, 2nd, 3rd, 5th, 7th and 15th postoperative days.
Change in hepatic function
Complete blood count(CBC), prothrombin time(PT), activated partial thromboplastin time(APTT), aspartate aminotransferase(AST), alanine aminotransferase(ALT), alkaline phosphatase(ALP), albumin, total bilirubin, direct bilirubin, gamma-GTP, BUN, creatinine(Cr), electrolyte
Measured: after operation, and on the 1st, 2nd, 3rd, 5th, 7th and 15th postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kasai OperationStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443572
- Sponsor's protocol ID
- 4-2011-0436
- Status last verified
- Jul 2014
- First submitted
- 16 Sep 2011
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Desflurane and Sevoflurane on Postoperative Recovery and Hepatic Function of Biliary Atresia Patients During Kasai Operation
- ClinicalTrials.gov ID
- NCT01443572
- Acronym / sponsor ID
- 4-2011-0436
- Conditions
- Kasai Operation, Biliary Atresia
- Keywords
- Kasai operation under general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 Sep 2011 (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.
Biliary atresia (BA) is a perinatal disease of unclear etiology, characterized by inflammation and obliteration of intrahepatic and extrahepatic bile ducts, leading to cholestasis and cirrhosis. Kasai operation remains as the first line operative treatment in BA. In the previous studies, inhalation anesthetics might induce liver damage. The choice of inhalation anesthetic that minimally affects hepatic function is important. Therefore, the purpose of this study is to compare the postoperative recovery and hepatic function between desflurane and sevoflurane, two most frequently used inhalational anesthetics in patients undergoing Kasai operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| desflurane group | Experimental | Drug: desflurane anesthetics |
| sevoflurane group | Active comparator | Drug: sevoflurane anesthetics |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients with biliary atresia undergoing Kasai operation
Key exclusion criteria (1 listed)
- patients with congenital anomalies at major organs
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 |
|---|---|---|
| desflurane anesthetics40 patients are randomly allocated into two groups : desflurane group (n=20) and sevoflurane group (n=20). And anesthesia is maintained with desflurane (desflurane group) or sevoflurane (sevoflurane group). | Drug | desflurane group |
| sevoflurane anesthetics40 patients are randomly allocated into two groups : desflurane group (n=20) and sevoflurane group (n=20). And anesthesia is maintained with desflurane (desflurane group) or sevoflurane (sevoflurane group). | Drug | sevoflurane group |
Primary outcome
Change in postoperative recovery
Time frame: after operation, and on the 1st, 2nd, 3rd, 5th, 7th and 15th postoperative days.
Complete blood count(CBC), prothrombin time(PT), activated partial thromboplastin time(APTT), aspartate aminotransferase(AST), alanine aminotransferase(ALT), alkaline phosphatase(ALP), albumin, total bilirubin, direct bilirubin, gamma-GTP, BUN, creatinine(Cr), electrolyte
Change in hepatic function
Time frame: after operation, and on the 1st, 2nd, 3rd, 5th, 7th and 15th postoperative days
Complete blood count(CBC), prothrombin time(PT), activated partial thromboplastin time(APTT), aspartate aminotransferase(AST), alanine aminotransferase(ALT), alkaline phosphatase(ALP), albumin, total bilirubin, direct bilirubin, gamma-GTP, BUN, creatinine(Cr), electrolyte
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 22 Jul 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing desflurane anesthetics and sevoflurane anesthetics in people with Kasai Operation and Biliary Atresia, run by Yonsei University at 1 site in South Korea.
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 22 Jul 2014. 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 South Korea. 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?
Change in postoperative recovery (time frame: after operation, and on the 1st, 2nd, 3rd, 5th, 7th and 15th postoperative days.). 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 22 Jul 2014.