Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 6:50 PM
Study NCT ID:
NCT05909033
Status:
UNKNOWN
Last Update Posted:
2023-06-18
First Post:
2023-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Predictors for the Short Term Native Liver Survival in Patients With Biliary Atresia After Kasai Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001656', 'term': 'Biliary Atresia'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011171', 'term': 'Portoenterostomy, Hepatic'}], 'ancestors': [{'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-09', 'studyFirstSubmitDate': '2023-06-08', 'studyFirstSubmitQcDate': '2023-06-09', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NLS rate', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'native liver survival rate'}], 'secondaryOutcomes': [{'measure': 'age at KP', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'age at kasai procedure'}, {'measure': 'PC', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'post cholangitis'}, {'measure': 'JC', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'jaudiance clearance'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biliary Atresia', 'Kasai procedure', 'early predictor', 'native liver survival'], 'conditions': ['Biliary Atresia']}, 'referencesModule': {'references': [{'pmid': '38189999', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Biliary atresia (BA) is the most common cause of neonatal cholestasis, occurring in approximately 1: 8000 to 1:15000 in Asian populations compared with those in Europe and the USA, with a ratio of 1: 1.56 in males and females.Until now, Kasai procedure(KP) remains the preferred treatment for biliary BA;however,nearly 60-70% patients after KP need liver transplants to achieve long-term survival.Therefore, it is meaningful to seek and analyze the factors affecting the native liver survival(NLS) 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 KP,and many factors have been proven that may affect NLS,including old age at KP,low gamma-glutamyl transpeptidase(GGT) level,Cytomegalovirus(CMV) Infection,early jaundice clearance(JC) and postoperative cholangitis(PC),etal.However,the predictors for NLS were not be finally detected.Otherwise,the safety of liver transplants has been improved in the past few years and performing liver transplant in young infants has been proven to be feasible.Then,it is important to seek early NLS predictors for counseling the necessity and timing of liver transplant.Unfortunately,early predictors of NLS focus on preoperative and early postoperative period after KP were insufficient.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '6 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with Biliary atreisa and were performed with kasai procedures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBiliary Atresia(BA) patients performed with Kasai Procedure patients completed the follow-up\\>6 months\n\nExclusion Criteria:\n\nBA patients without KP patients lost of follow-up BA patients with other severe complications lead to death'}, 'identificationModule': {'nctId': 'NCT05909033', 'briefTitle': 'Early Predictors for the Short Term Native Liver Survival in Patients With Biliary Atresia After Kasai Procedure', 'organization': {'class': 'OTHER', 'fullName': "Nanjing Children's Hospital"}, 'officialTitle': 'Early Predictors for the Short Term Native Liver Survival in Patients With Biliary Atresia After Kasai Procedure', 'orgStudyIdInfo': {'id': 'NanjingCH20230601'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Kasai procedure', 'type': 'PROCEDURE', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changgui Lu, Dr', 'role': 'CONTACT', 'email': 'luchanggui1984@163.com'}], 'facility': "Children's Hospital of Nanjing Medical University", 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Changgui Lu, Dr', 'role': 'CONTACT', 'email': 'luchanggui1984@163.com', 'phone': '13770848448'}], 'overallOfficials': [{'name': 'Weibing Tang, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': "Children's Hospital of Nanjing Medical University"}, {'name': 'Weibing Tang, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Nanjing Medical University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weibing Tang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Weibing Tang', 'investigatorAffiliation': "Nanjing Children's Hospital"}}}}