Clinical trial NCT06163417: Laparoscopic Kasai Has Similar Anesthetic Outcomes to Open Kasai
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Atresia
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective cohort study was conducted at a single tertiary center in central Taiwan.

Brief 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. 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

Eligibility criteria: 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.

Primary outcomes:
measure: fluid intake_1
timeFrame: through study completion, an average of 1 year
measure: fluid intake_2
timeFrame: through study completion, an average of 1 year
measure: output_1
timeFrame: through study completion, an average of 1 year
measure: output_2
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: respiratory outcomes_1
timeFrame: through study completion, an average of 1 year
measure: respiratory outcomes_2
timeFrame: through study completion, an average of 1 year
measure: respiratory outcomes_3
timeFrame: through study completion, an average of 1 year
measure: surgery duration of the surgery
timeFrame: through study completion, an average of 1 year
measure: total days of hospitalization
timeFrame: through study completion, an average of 1 year
measure: total days of admission to ICU
timeFrame: through study completion, an average of 1 year
measure: surgery-related outcomes_1
timeFrame: through study completion, an average of 1 year
measure: surgery-related outcomes_2
timeFrame: through study completion, an average of 1 year
measure: surgery-related outcomes_3
timeFrame: through study completion, an average of 1 year
measure: surgery-related outcomes_4
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
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