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Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study

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ClinicalTrials.gov Identifier: NCT03842150
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
Better survival and prognosis of biliary atresia (BA) depend on early diagnosis and timely Kasai portoenterostomy. Identifying BA from other causes of infantile cholestasis at early stage of the disease still remains a major challenge. In this study, the investigators aim to develop and validate a scoring system to screen BA in infants with cholestasis.

Condition or disease Intervention/treatment
Biliary Atresia Neonatal Cholestasis Infantile Hepatitis Syndrome Diagnostic Test: biliary atresia screen score

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study
Actual Study Start Date : June 1, 2014
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
derivation cohort Diagnostic Test: biliary atresia screen score
The investigators aim to develop a scoring system according to clinical, laboratory, imaging features of biliary atresia in the derivation dataset and tested in the validation datasets.

validation cohort Diagnostic Test: biliary atresia screen score
The investigators aim to develop a scoring system according to clinical, laboratory, imaging features of biliary atresia in the derivation dataset and tested in the validation datasets.




Primary Outcome Measures :
  1. Development and Validation a Screening Score for the biliary atresia in infantile cholestasis [ Time Frame: 1 weeks ]
    Developed a scoring system according to clinical, laboratory, imaging features of BA and test it in the clinical work. The score system might including clay stool, γ-glutamyl transpeptadase, the results of ultrasound and subscales selected for logistic regression. The total score would sum all the subscales up.The investigators grade the patients with the cholestasis screen score to identify patients with biliary atresia. Patients with score ≤ 15 points considered to be the low-risk group, and patients with risk score > 15 points considered the high-risk group, and the score model has no maximum or minimum value.



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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
infants with cholestasis inclduing biliary atresia
Criteria

Inclusion Criteria:

Clinical diagnosis of neonatal cholestasis Age at first visit less than 90 days after birth

Exclusion Criteria:

Severe congenital malformation Subjects with missing data


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842150


Contacts
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Contact: Yongjun Zhang, doctor +8602125078310 zhangyongjun@sjtu.edu.cn

Locations
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China, Shanghai
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: Yongjun Zhang, doctor         
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03842150     History of Changes
Other Study ID Numbers: XH-19-001
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators plan to share all the individual participant data information available to our cooperative hospitals through emails

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cholestasis
Biliary Atresia
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Abnormalities
Congenital Abnormalities