- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06163417
Laparoscopic Kasai Has Similar Anesthetic Outcomes to Open Kasai
Laparoscopic Kasai Portoenterostomy Has Similar Surgical Outcomes and Better Urine Output Compared to Standard Open Kasai- Portoenterostomy: A Ten-year Retrospective Cohort Study
Study Overview
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- children who had undergone Kasai portoenterostomy between January 2011 and December 2021
Exclusion Criteria:
- severe congenital heart disease requiring surgical treatment,
- reoperation,
- a diagnosis of non-biliary atresia,
- incomplete medical records.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
O group
conventional Kasai portoenterostomy
|
|
L group
laparoscopic Kasai portoenterostomy
|
laparoscopic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fluid intake_1
Time Frame: through study completion, an average of 1 year
|
intravenous fluid infusion during the operation ( ml)
|
through study completion, an average of 1 year
|
fluid intake_2
Time Frame: through study completion, an average of 1 year
|
transfusion volume during the operation (ml)
|
through study completion, an average of 1 year
|
output_1
Time Frame: through study completion, an average of 1 year
|
urine output
|
through study completion, an average of 1 year
|
output_2
Time Frame: through study completion, an average of 1 year
|
blood loss (ml)
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
respiratory outcomes_1
Time Frame: through study completion, an average of 1 year
|
extubation time ( duration between extubation and end of the surgery)
|
through study completion, an average of 1 year
|
respiratory outcomes_2
Time Frame: through study completion, an average of 1 year
|
EtCO2
|
through study completion, an average of 1 year
|
respiratory outcomes_3
Time Frame: through study completion, an average of 1 year
|
peak airway pressure
|
through study completion, an average of 1 year
|
surgery duration of the surgery
Time Frame: through study completion, an average of 1 year
|
total surgery time
|
through study completion, an average of 1 year
|
total days of hospitalization
Time Frame: through study completion, an average of 1 year
|
total hospital days
|
through study completion, an average of 1 year
|
total days of admission to ICU
Time Frame: through study completion, an average of 1 year
|
total ICU days
|
through study completion, an average of 1 year
|
surgery-related outcomes_1
Time Frame: through study completion, an average of 1 year
|
postoperative day 1 liver function ( GOT, GPT,bilirubin in the postoperative day 1)
|
through study completion, an average of 1 year
|
surgery-related outcomes_2
Time Frame: through study completion, an average of 1 year
|
native liver survival time ( duration before liver transplantation)
|
through study completion, an average of 1 year
|
surgery-related outcomes_3
Time Frame: through study completion, an average of 1 year
|
cholangitis ( cholangitis needes antibiotics treatment)
|
through study completion, an average of 1 year
|
surgery-related outcomes_4
Time Frame: through study completion, an average of 1 year
|
6-month bilirubin clearance rate ( bilirubin below standard rate at 6-month)
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE22128A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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