Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007212

Trial Description

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Title

Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism

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Trial Acronym

non-focal CHI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Observational study in patients with non-focal congenital hyperinsulinism showing that
restrictive surgery may improve the metabolic situation

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Brief Summary in Scientific Language

In non-focal congenital hyperinsulinism (CHI) the current doctrine warrants subtotal
pancreatic resection in all children who do not respond to medication. However, the rate of
diabetes after these extensive resections is very high. In this study investigators show
that a less aggressive approach may suffice to wean many children from all medication or to
get them manageable medically.

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Organizational Data

  •   DRKS00007212
  •   2016/01/28
  •   2014/03/28
  •   yes
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Secondary IDs

  •   NCT02108730  (ClinicalTrials.gov)
  •   123456  (University Medicine Greifswald)
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Health Condition or Problem studied

  •   Non-focal Congenital Hyperinsulinism
  •   E16.1 -  Other hypoglycaemia
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Interventions/Observational Groups

  •   Procedure: restrictive pancreatic resection
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- necessity of medication after restrictive surgery in congenital hyperinsulinism; time frame: up to 3 years

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2011/03/31
  •   14
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- patients with non-focal congenital hyperinsulinism

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Exclusion Criteria

- patients with focal congenital hyperinsulinism

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Addresses

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    • University Medicine Greifswald
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    • University Medicine Greifswald
    • Winfried Barthlen, Professor of Pediatric Surgery 
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    • University Medicine Greifswald
    • Winfried Barthlen, Professor of Pediatric Surgery 
    end of 1:1-Block address public-contact
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2014/03/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.