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Trial record 6 of 28 for:    "Persistent Hyperinsulinemia Hypoglycemia of Infancy" OR "familial hyperinsulinism"

Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism (non-focal CHI)

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ClinicalTrials.gov Identifier: NCT02108730
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : April 9, 2014
Sponsor:
Information provided by (Responsible Party):
Prof. Winfried Barthlen, University Medicine Greifswald

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

Condition or disease Intervention/treatment
Non-focal Congenital Hyperinsulinism Procedure: restrictive pancreatic resection

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism
Study Start Date : March 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
non-focal congenital hyperinsulinism
13 children and one adult with non-focal congenital hyperinsulinism
Procedure: restrictive pancreatic resection
Restrictive, spleen-preserving resection of the pancreatic tail by laparoscopy



Primary Outcome Measures :
  1. necessity of medication after restrictive surgery in congenital hyperinsulinism [ Time Frame: up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
13 children and one adult (30 years)
Criteria

Inclusion Criteria:

  • patients with non-focal congenital hyperinsulinism

Exclusion Criteria:

  • patients with focal congenital hyperinsulinism

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): NCT02108730


Locations
Germany
Pediatric Surgery
Greifswald, Germany, D-17475
Sponsors and Collaborators
University Medicine Greifswald
Investigators
Principal Investigator: Winfried Barthlen, Professor of Pediatric Surgery University Medicine Greifswald

Additional Information:
Responsible Party: Prof. Winfried Barthlen, Professor of Pediatric surgery, University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT02108730     History of Changes
Other Study ID Numbers: 123456
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Hyperinsulinism
Congenital Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Hypoglycemia