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Maternal Microchimerism in Lymph Nodes of Infants With Biliary Atresia at Time of Kasai's Operation (K-LNMC)

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ClinicalTrials.gov Identifier: NCT02292862
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : November 17, 2014
Sponsor:
Collaborator:
Johann Wolfgang Goethe University Hospital
Information provided by (Responsible Party):
Carsten Engelmann, Medizinische Hochschule Brandenburg Theodor Fontane

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.


Condition or disease Intervention/treatment
Biliary Atresia Procedure: Lymph node and blood sampling

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Search for Maternal Microchimerism in Swollen Portal Lymph Nodes of Infants With Biliary Atresia.
Study Start Date : November 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MG Main Group
lymph node and blood sampling
Procedure: Lymph node and blood sampling

By bipolar dissection 1 portal and 1 mesenteric lymph node are removed from the infant.

Blood (1ml) is taken from mother and infant.





Primary Outcome Measures :
  1. Maternal DNA in offspring [ Time Frame: 3 months ]
    The presence of maternal DNA in the childs blood and lymph nodes is the endpoint


Secondary Outcome Measures :
  1. Serum Bilirubin [ Time Frame: perioperatively ]
  2. Composition of lymphocyte population in mesenteric lymph nodes [ Time Frame: 3 months ]

Biospecimen Retention:   Samples With DNA
Lymph nodes from children Whole Blood from mother and infant


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Ages Eligible for Study:   up to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with newly and preoperatively diagnosed infantile Biliary Atresia of the non-syndromatic form
Criteria

Inclusion Criteria:

  • Non-Syndromatic Form of Biliary Atresia

Exclusion Criteria:

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

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): NCT02292862


Locations
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Germany
Pediatric Surgery Department
Hannover, Lower Saxony, Germany, 30625
Sponsors and Collaborators
Medizinische Hochschule Brandenburg Theodor Fontane
Johann Wolfgang Goethe University Hospital
Investigators
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Principal Investigator: Carsten R Engelmann, MD, OhD Klinikum Brandenburg

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carsten Engelmann, Head of Department, Medizinische Hochschule Brandenburg Theodor Fontane
ClinicalTrials.gov Identifier: NCT02292862     History of Changes
Other Study ID Numbers: Trial 1650 12
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: November 2014

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