NCT05909033

Brief Summary

Many factors have been proven that may affect NLS in BA patients after KP;however,the early predictors for NLS were not be finally detected.This study was designed to evaluate and identify the preoperative and early postoperative factors associated with NLS for early prediction in BA patients after KP.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 20, 2017

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

6.1 years

First QC Date

June 8, 2023

Last Update Submit

June 9, 2023

Conditions

Keywords

biliary AtresiaKasai procedureearly predictornative liver survival

Outcome Measures

Primary Outcomes (1)

  • NLS rate

    native liver survival rate

    through study completion, an average of 3 years

Secondary Outcomes (3)

  • age at KP

    through study completion, an average of 3 years

  • PC

    through study completion, an average of 3 years

  • JC

    through study completion, an average of 3 years

Interventions

All KPs were performed by a medical team. This technique involved creation of a 35-40 cm Roux loop to facilitate biliary drainage. After dissection of the hepatic vasculature at the hilum and excision of the hilar plate, hepaticojejunostomy was performed as an anastomosis extending from the bifurcation of the right hepatic artery into anterior and posterior branches to the Rex confluence of the left portal vein with the obliterated umbilical vein.

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

patients with Biliary atreisa and were performed with kasai procedures

You may qualify if:

  • Biliary Atresia(BA) patients performed with Kasai Procedure patients completed the follow-up\>6 months

You may not qualify if:

  • BA patients without KP patients lost of follow-up BA patients with other severe complications lead to death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Nanjing Medical University

Nanjing, 210008, China

RECRUITING

Related Publications (1)

  • Lu C, Xie H, Zhu Z, Ding Z, Geng Q, Tang W. A convenient nomogram for predicting early death or liver transplantation after the Kasai procedure in patients with biliary atresia. Langenbecks Arch Surg. 2024 Jan 8;409(1):30. doi: 10.1007/s00423-023-03216-5.

MeSH Terms

Conditions

Biliary Atresia

Interventions

Portoenterostomy, Hepatic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeBiliary Tract Surgical ProceduresDigestive System Surgical Procedures

Study Officials

  • Weibing Tang, Dr

    Children's Hospital of Nanjing Medical University

    STUDY DIRECTOR
  • Weibing Tang, Dr

    Children's Hospital of Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Changgui Lu, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 8, 2023

First Posted

June 18, 2023

Study Start

May 20, 2017

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Locations