Laparoscopic Kasai Has Similar Anesthetic Outcomes to Open Kasai

November 30, 2023 updated by: Taichung Veterans General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

28

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This retrospective cohort study was conducted at a single tertiary center in central Taiwan.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

March 28, 2023

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Estimated)

December 8, 2023

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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