NCT06163417

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
Last Updated

December 8, 2023

Status Verified

November 1, 2023

Enrollment Period

11 years

First QC Date

November 14, 2023

Last Update Submit

November 30, 2023

Conditions

Biliary Atresia

Outcome Measures

Primary Outcomes (4)

  • fluid intake_1

    intravenous fluid infusion during the operation ( ml)

    through study completion, an average of 1 year

  • fluid intake_2

    transfusion volume during the operation (ml)

    through study completion, an average of 1 year

  • output_1

    urine output

    through study completion, an average of 1 year

  • output_2

    blood loss (ml)

    through study completion, an average of 1 year

Secondary Outcomes (10)

  • respiratory outcomes_1

    through study completion, an average of 1 year

  • respiratory outcomes_2

    through study completion, an average of 1 year

  • respiratory outcomes_3

    through study completion, an average of 1 year

  • surgery duration of the surgery

    through study completion, an average of 1 year

  • total days of hospitalization

    through study completion, an average of 1 year

  • +5 more secondary outcomes

Study Arms (2)

O group

conventional Kasai portoenterostomy

L group

laparoscopic Kasai portoenterostomy

Procedure: laparoscopic

Interventions

laparoscopicPROCEDURE

laparoscopic

L group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • children who had undergone Kasai portoenterostomy between January 2011 and December 2021

You may not qualify if:

  • severe congenital heart disease requiring surgical treatment,
  • reoperation,
  • a diagnosis of non-biliary atresia,
  • incomplete medical records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Biliary Atresia

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesDigestive System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

December 8, 2023

Study Start

January 1, 2011

Primary Completion

December 31, 2021

Study Completion

March 28, 2023

Last Updated

December 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share