Viewing Study NCT05909033



Ignite Creation Date: 2024-05-06 @ 7:07 PM
Last Modification Date: 2024-10-26 @ 3:01 PM
Study NCT ID: NCT05909033
Status: RECRUITING
Last Update Posted: 2023-06-18
First Post: 2023-06-08

Brief Title: Early Predictors for the Short Term Native Liver Survival in Patients With Biliary Atresia After Kasai Procedure
Sponsor: Weibing Tang
Organization: Nanjing Childrens Hospital

Study Overview

Official Title: Early Predictors for the Short Term Native Liver Survival in Patients With Biliary Atresia After Kasai Procedure
Status: RECRUITING
Status Verified Date: 2023-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Many factors have been proven that may affect NLS in BA patients after KPhoweverthe early predictors for NLS were not be finally detectedThis study was designed to evaluate and identify the preoperative and early postoperative factors associated with NLS for early prediction in BA patients after KP
Detailed Description: Biliary atresia BA is the most common cause of neonatal cholestasis occurring in approximately 1 8000 to 115000 in Asian populations compared with those in Europe and the USA with a ratio of 1 156 in males and femalesUntil now Kasai procedureKP remains the preferred treatment for biliary BAhowevernearly 60-70 patients after KP need liver transplants to achieve long-term survivalTherefore it is meaningful to seek and analyze the factors affecting the native liver survivalNLS in BA patients with KP for prediction Luckily A lot of studies have designed to seek the risk factors for death or liver transplants in BA patients after KPand many factors have been proven that may affect NLSincluding old age at KPlow gamma-glutamyl transpeptidaseGGT levelCytomegalovirusCMV Infectionearly jaundice clearanceJC and postoperative cholangitisPCetalHoweverthe predictors for NLS were not be finally detectedOtherwisethe safety of liver transplants has been improved in the past few years and performing liver transplant in young infants has been proven to be feasibleThenit is important to seek early NLS predictors for counseling the necessity and timing of liver transplantUnfortunatelyearly predictors of NLS focus on preoperative and early postoperative period after KP were insufficient

This study is primarily designed to evaluate and identify the preoperative and early postoperative factors associated with NLS for early prediction in BA patients after KP

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None