Trial record 6 of 15 for:    "Persistent Hyperinsulinemia Hypoglycemia of Infancy" OR "familial hyperinsulinism"

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

This study has been completed.
Information provided by (Responsible Party):
Prof. Winfried Barthlen, University Medicine Greifswald Identifier:
First received: March 28, 2014
Last updated: April 8, 2014
Last verified: April 2014
Observational study in patients with non-focal congenital hyperinsulinism showing that restrictive surgery may improve the metabolic situation

Condition Intervention
Non-focal Congenital Hyperinsulinism
Procedure: restrictive pancreatic resection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism

Resource links provided by NLM:

Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • necessity of medication after restrictive surgery in congenital hyperinsulinism [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: March 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
13 children and one adult (30 years)

Inclusion Criteria:

  • patients with non-focal congenital hyperinsulinism

Exclusion Criteria:

  • patients with focal congenital hyperinsulinism
  Contacts and Locations
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Please refer to this study by its identifier: NCT02108730

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

Additional Information:
No publications provided

Responsible Party: Prof. Winfried Barthlen, Professor of Pediatric surgery, University Medicine Greifswald Identifier: NCT02108730     History of Changes
Other Study ID Numbers: 123456
Study First Received: March 28, 2014
Last Updated: April 8, 2014
Health Authority: Germany: Federal Ministry of Education and Research

Additional relevant MeSH terms:
Congenital Hyperinsulinism
Digestive System Diseases
Glucose Metabolism Disorders
Infant, Newborn, Diseases
Metabolic Diseases
Pancreatic Diseases processed this record on November 24, 2015