NCT02292862

Brief Summary

Maternal microchimerism has been discussed as an etiological mechanism in infantile (perinatal) biliary atresia (BA). In Kasai's operation (resection of the liver hilum plaque followed by hepato-portoenterostomy) surgeons frequently encounter swollen portal and mesenteric lymph nodes. Lymph nodes were sampled during Kasai' s operation and examined for maternal DNA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

November 13, 2014

Last Update Submit

November 14, 2014

Conditions

Biliary Atresia

Outcome Measures

Primary Outcomes (1)

  • Maternal DNA in offspring

    The presence of maternal DNA in the childs blood and lymph nodes is the endpoint

    3 months

Secondary Outcomes (2)

  • Serum Bilirubin

    perioperatively

  • Composition of lymphocyte population in mesenteric lymph nodes

    3 months

Study Arms (1)

MG Main Group

lymph node and blood sampling

Procedure: Lymph node and blood sampling

Interventions

Lymph node and blood samplingPROCEDURE

By bipolar dissection 1 portal and 1 mesenteric lymph node are removed from the infant. Blood (1ml) is taken from mother and infant.

MG Main Group

Eligibility Criteria

Age4 Weeks - 5 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with newly and preoperatively diagnosed infantile Biliary Atresia of the non-syndromatic form

You may qualify if:

  • Non-Syndromatic Form of Biliary Atresia

You may not qualify if:

  • Syndromatic Form of Biliary Atresia
  • Other Congenital Liver Disease (Like Alagilles' Syndrome)
  • No liver fibrosis/cirrhosis in Histology of LIver Specimen from Routine Histology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Surgery Department

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (3)

  • Leveque L, Hodgson S, Peyton S, Koyama M, MacDonald KP, Khosrotehrani K. Selective organ specific inflammation in offspring harbouring microchimerism from strongly alloreactive mothers. J Autoimmun. 2014 May;50:51-8. doi: 10.1016/j.jaut.2013.10.005. Epub 2013 Nov 20.

    PMID: 24268809BACKGROUND

  • Willasch A, Schneider G, Reincke BS, Shayegi N, Kreyenberg H, Kuci S, Weber G, Van Der Reijden B, Niethammer D, Klingebiel T, Bader P. Sequence polymorphism systems for quantitative real-time polymerase chain reaction to characterize hematopoietic chimerism-high informativity and sensitivity as well as excellent reproducibility and precision of measurement. Lab Hematol. 2007;13(3):73-84.

    PMID: 17984038BACKGROUND

  • Engelmann C, Maelzer M, Kreyenberg H. Absence of Maternal Microchimerism in Regional Lymph Nodes of Children With Biliary Atresia. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):804-7. doi: 10.1097/MPG.0000000000001093.

    PMID: 26756872DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Lymph nodes from children Whole Blood from mother and infant

MeSH Terms

Conditions

Biliary Atresia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Carsten R Engelmann, MD, OhD

    Klinikum Brandenburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

November 13, 2014

First Posted

November 17, 2014

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2014

Last Updated

November 17, 2014

Record last verified: 2014-11

Locations

DE(1)