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Citation
Brown, Morton (2020). Assessment of Inter-Observer Variability in the Histological Diagnosis of Infantile Cholestasis (P002) (Version 1) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/b0yw-j370
Data Availability Statement
Data from the Assessment of Inter-Observer Variability in the Histological Diagnosis of Infantile Cholestasis (P002) [(Version 1) https://doi.org/10.58020/b0yw-j370] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgement Statement
The P002 study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the P002 (https://doi.org/10.58020/b0yw-j370) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the P002 study and does not necessarily reflect the opinions or views of the P002 study, NIDDK-CR, or NIDDK.
Data Package Version
Version 1 (Updated on: Dec 16, 2020)
Resource Availability
  • Data Available for Request
  • Specimens Not Available
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General Description

Infants with cholestasis prior to 181 days of age present a challenging diagnostic problem of differentiation between an extra- and intra-hepatic location of the cholestatic process. This assessment is critical, since any evidence of obstruction essentially mandates surgical exploration. Extrahepatic biliary atresia (EHBA) is the most frequent cause of persistent unrelieved infant jaundice amenable to surgical correction.

This is a retrospective multi-center pathology project, which will examine interobserver variability in the histological diagnosis of infantile cholestasis with the aim of establishing reliable histological criteria of extra-hepatic obstruction in infants.

Objectives

The evaluation of liver biopsies is a cornerstone in the work-up of the infant with cholestasis. The primary purpose of this project is to test interobserver variability in the histopathological assessment of liver biopsies taken from cholestatic infants < 181 days of age.

There are 3 major aims of this study: firstly, to determine the reliability and reproducibility of several pathologists to distinguish, on a liver biopsy, histological changes pointing to an extra-hepatic obstructive process. Secondly: to develop a set of criteria that could be reliably and confidently identified by pathologists with variable levels of expertise, practicing at different centers, to diagnose obstruction. And thirdly: To develop a standardized assessment of fibrosis on a liver biopsy of a child with biliary atresia for the purposes of prognostication.

Outcome Measure

There are no outcome measures for this study.

Eligibility Criteria

This is a retrospective study of infants <181 days with cholestasis for whom the pathologist at the institution can provide representative slides from their liver biopsy or biopsies. Therefore, the inclusion/exclusion criteria describe the biopsy, as well as the subject.

Inclusion Criteria:

  • Patients who were infants at the time of biopsy, which was performed during the period between 01/01/2002 and 12/31/2002, and for which there was either a final clinical diagnosis available or imaging assessment that determined the presence or absence of an obstruction will be considered for this study.

Exclusion Criteria:

  • Patients for whom there is an inability to provide two representative slides from the liver biopsy will not be included in this study.

Research Area

Kidney Disease

Study Type

Observational

Study Sites

150

Condition

Biliary Atresia, Cholestasis, Bile Duct Disorder

Keywords

Extrahepatic Biliary Atresia (EHBA), Liver Biopsy, Interobservor, Cholestasis, Cholestatic Process, Prognostication, Intra-Hepatic, Fibrosis

NIDDK Division

Division of Digestive Diseases and Nutrition

106
Participants

Target Population
Children

Public Documents Table
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Datasets (2)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
Pathology Scoresheet Dataset
This dataset from the P002 protocol contains 931 observations, with variables from the Pathology form. Data includes biopsy results.931sas7bdat (1.05 MB); csv (89.95 KB)
Coordinator Dataset
This dataset from the P002 protocol contains 106 observations, with variables from the Coordinator form. Data includes demographic information, laboratory test results, biopsy history, and some medical history. 106sas7bdat (97 KB); csv (41.92 KB)
Specimens (0)
There are currently no specimens available