Biliary AtresiaNCT06163417
Laparoscopic Kasai Has Similar Anesthetic Outcomes to Open Kasai
An observational study of Biliary Atresia, run by Taichung Veterans General Hospital.
Trial summary
Biliary atresia (BA) is a rare biliary tree disease with a high incidence in eastern Asia. Kasai operation is a standard treatment for BA, and studies have shown that timely Kasai operation is crucial for better outcomes. The Kasai operation can be performed as either an open or laparoscopic technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biliary Atresia
- What is being tested?
- laparoscopic
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 28 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective cohort study was conducted at a single tertiary center in central Taiwan.
Who may be able to join
- children who had undergone Kasai portoenterostomy between January 2011 and December 2021
Who cannot join
- severe congenital heart disease requiring surgical treatment,
- reoperation,
- a diagnosis of non-biliary atresia,
- incomplete medical records.
About this study
Official title: Laparoscopic Kasai Portoenterostomy Has Similar Surgical Outcomes and Better Urine Output Compared to Standard Open Kasai- Portoenterostomy: A Ten-year Retrospective Cohort Study
Biliary atresia (BA) is a rare biliary tree disease with a high incidence in eastern Asia. Kasai operation is a standard treatment for BA, and studies have shown that timely Kasai operation is crucial for better outcomes. The Kasai operation can be performed as either an open or laparoscopic technique. This study aimed to compare the differences in anesthetic management between the two surgical groups. Herein, we compared the outcomes of infants with BA who underwent the open and laparoscopic Kasai surgery.
Read the detailed description
Biliary atresia is (BA) a rare biliary tree disease. This disease, which is usually found in infancy is characterized by biliary inflammation and obliteration. The incidence variate from 1 in 5000 to 20000. However, high prevalence rate up to 1 in 5-10,000 was comparatively noted in eastern Asia, especially in Japan and Taiwan. Biliary atresia can be treated by "Kasai operation" ( Kasai portoenterotomy) or liver transplantation. In the previous study, 60% of biliary atresia patients after receiving Kasai portoenterostomy could have better liver prognosis.The timing of Kasai operation is also crucial, increased age of surgery had negative influence in the long-term follow up.
Traditionally, Kasai portoenterostomy was performed by open surgery. As the progression and popularity of minimally invasive surgery, laparoscopic Kasai was first introduced in 2002 and then performed in many countries. However, the advantage of laparoscopic Kasai seems still controversial due to many indicative outcomes as early jaundice clearance, native liver survival (NLS) and liver transplantation rate within 1 year after the Kasai operation even adhesions prevention seems no better maybe worse in laparoscopic group.But in our hospital, no statistically significant differences were observed for hospital stay and outcomes (including early jaundice clearance rate, episodes of cholangitis, and 2-year native liver survival rate) between the open and the laparoscopic Kasai operations.Even the better operation view was noted in laparoscopic group but operation time seems almost all prolonged in laparoscopic one compared to open one, that makes excessive fluid infusion and hypothermia easily found in laparoscopic group . However, no hypothermia and laryngeal edema were noted in our hospital compare to previous study
- Conditions
- Biliary Atresia
- Being tested
- laparoscopic
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopicProcedure or surgery
laparoscopic
| Study group | Role | What they receive |
|---|---|---|
| O group | conventional Kasai portoenterostomy | |
| L group | laparoscopic Kasai portoenterostomy Receives: Procedure: laparoscopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid intake_1
intravenous fluid infusion during the operation ( ml)
Measured: through study completion, an average of 1 year
fluid intake_2
transfusion volume during the operation (ml)
Measured: through study completion, an average of 1 year
output_1
urine output
Measured: through study completion, an average of 1 year
output_2
blood loss (ml)
Measured: through study completion, an average of 1 year
Secondary outcomes (10)
respiratory outcomes_1
extubation time ( duration between extubation and end of the surgery)
Measured: through study completion, an average of 1 year
respiratory outcomes_2
EtCO2
Measured: through study completion, an average of 1 year
respiratory outcomes_3
peak airway pressure
Measured: through study completion, an average of 1 year
surgery duration of the surgery
total surgery time
Measured: through study completion, an average of 1 year
total days of hospitalization
total hospital days
Measured: through study completion, an average of 1 year
total days of admission to ICU
total ICU days
Measured: through study completion, an average of 1 year
surgery-related outcomes_1
postoperative day 1 liver function ( GOT, GPT,bilirubin in the postoperative day 1)
Measured: through study completion, an average of 1 year
surgery-related outcomes_2
native liver survival time ( duration before liver transplantation)
Measured: through study completion, an average of 1 year
surgery-related outcomes_3
cholangitis ( cholangitis needes antibiotics treatment)
Measured: through study completion, an average of 1 year
surgery-related outcomes_4
6-month bilirubin clearance rate ( bilirubin below standard rate at 6-month)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Jan 2011
- Primary completion31 Dec 2021
- Study completion28 Mar 2023
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 Taichung Veterans General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163417
- Sponsor's protocol ID
- CE22128A
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Kasai Portoenterostomy Has Similar Surgical Outcomes and Better Urine Output Compared to Standard Open Kasai- Portoenterostomy: A Ten-year Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06163417
- Acronym / sponsor ID
- CE22128A
- Conditions
- Biliary Atresia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 8 Dec 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.
Biliary atresia (BA) is a rare biliary tree disease with a high incidence in eastern Asia. Kasai operation is a standard treatment for BA, and studies have shown that timely Kasai operation is crucial for better outcomes. The Kasai operation can be performed as either an open or laparoscopic technique. This study aimed to compare the differences in anesthetic management between the two surgical groups. Herein, we compared the outcomes of infants with BA who underwent the open and laparoscopic Kasai surgery.
Detailed description
Biliary atresia is (BA) a rare biliary tree disease. This disease, which is usually found in infancy is characterized by biliary inflammation and obliteration. The incidence variate from 1 in 5000 to 20000. However, high prevalence rate up to 1 in 5-10,000 was comparatively noted in eastern Asia, especially in Japan and Taiwan. Biliary atresia can be treated by "Kasai operation" ( Kasai portoenterotomy) or liver transplantation. In the previous study, 60% of biliary atresia patients after receiving Kasai portoenterostomy could have better liver prognosis.The timing of Kasai operation is also crucial, increased age of surgery had negative influence in the long-term follow up.
Traditionally, Kasai portoenterostomy was performed by open surgery. As the progression and popularity of minimally invasive surgery, laparoscopic Kasai was first introduced in 2002 and then performed in many countries. However, the advantage of laparoscopic Kasai seems still controversial due to many indicative outcomes as early jaundice clearance, native liver survival (NLS) and liver transplantation rate within 1 year after the Kasai operation even adhesions prevention seems no better maybe worse in laparoscopic group.But in our hospital, no statistically significant differences were observed for hospital stay and outcomes (including early jaundice clearance rate, episodes of cholangitis, and 2-year native liver survival rate) between the open and the laparoscopic Kasai operations.Even the better operation view was noted in laparoscopic group but operation time seems almost all prolonged in laparoscopic one compared to open one, that makes excessive fluid infusion and hypothermia easily found in laparoscopic group . However, no hypothermia and laryngeal edema were noted in our hospital compare to previous study
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| O group | – | –conventional Kasai portoenterostomy |
| L group | – | Procedure: laparoscopiclaparoscopic Kasai portoenterostomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective cohort study was conducted at a single tertiary center in central Taiwan.
Key inclusion criteria (1 listed)
- children who had undergone Kasai portoenterostomy between January 2011 and December 2021
Key exclusion criteria (4 listed)
- severe congenital heart disease requiring surgical treatment,
- reoperation,
- a diagnosis of non-biliary atresia,
- incomplete medical records.
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 |
|---|---|---|
| laparoscopiclaparoscopic | Procedure or surgery | L group |
Primary outcome
fluid intake_1
Time frame: through study completion, an average of 1 year
intravenous fluid infusion during the operation ( ml)
fluid intake_2
Time frame: through study completion, an average of 1 year
transfusion volume during the operation (ml)
output_1
Time frame: through study completion, an average of 1 year
urine output
output_2
Time frame: through study completion, an average of 1 year
blood loss (ml)
10 secondary outcomes
respiratory outcomes_1
Time frame: through study completion, an average of 1 year
respiratory outcomes_2
Time frame: through study completion, an average of 1 year
respiratory outcomes_3
Time frame: through study completion, an average of 1 year
surgery duration of the surgery
Time frame: through study completion, an average of 1 year
total days of hospitalization
Time frame: through study completion, an average of 1 year
total days of admission to ICU
Time frame: through study completion, an average of 1 year
surgery-related outcomes_1
Time frame: through study completion, an average of 1 year
surgery-related outcomes_2
Time frame: through study completion, an average of 1 year
surgery-related outcomes_3
Time frame: through study completion, an average of 1 year
surgery-related outcomes_4
Time frame: through study completion, an average of 1 year
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 8 Dec 2023.
- Individual participant dataSharing planned: No
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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 Taichung Veterans General Hospital.
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 4 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 8 Dec 2023. 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?
fluid intake_1 (time frame: through study completion, an average of 1 year). The study lists 4 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 8 Dec 2023.