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NCT Number: NCT06163417

Laparoscopic Kasai Has Similar Anesthetic Outcomes to Open Kasai

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.

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Key information

Conditions

Biliary Atresia Bile Duct Diseases Biliary Tract Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic

Procedure

laparoscopic

Primary outcomes

  1. fluid intake_1

    Time frame: through study completion, an average of 1 year

    intravenous fluid infusion during the operation ( ml)

  2. fluid intake_2

    Time frame: through study completion, an average of 1 year

    transfusion volume during the operation (ml)

  3. output_1

    Time frame: through study completion, an average of 1 year

    urine output

  4. output_2

    Time frame: through study completion, an average of 1 year

    blood loss (ml)

Secondary outcomes

  1. respiratory outcomes_1

    Time frame: through study completion, an average of 1 year

    extubation time ( duration between extubation and end of the surgery)

  2. respiratory outcomes_2

    Time frame: through study completion, an average of 1 year

    EtCO2

  3. respiratory outcomes_3

    Time frame: through study completion, an average of 1 year

    peak airway pressure

  4. surgery duration of the surgery

    Time frame: through study completion, an average of 1 year

    total surgery time

  5. total days of hospitalization

    Time frame: through study completion, an average of 1 year

    total hospital days

  6. total days of admission to ICU

    Time frame: through study completion, an average of 1 year

    total ICU days

  7. 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)

  8. surgery-related outcomes_2

    Time frame: through study completion, an average of 1 year

    native liver survival time ( duration before liver transplantation)

  9. surgery-related outcomes_3

    Time frame: through study completion, an average of 1 year

    cholangitis ( cholangitis needes antibiotics treatment)

  10. 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)

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

Laparoscopic Kasai Portoenterostomy Has Similar Surgical Outcomes and Better Urine Output Compared to Standard Open Kasai- Portoenterostomy: A Ten-year Retrospective Cohort Study

Important dates

Study start
2011
Primary completion
2021
Study completion
2023
First posted
Dec 8, 2023
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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