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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Winfried Barthlen, University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT02108730
First received: March 28, 2014
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Winfried Barthlen, Professor of Pediatric surgery, University Medicine Greifswald
ClinicalTrials.gov 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:
Hyperinsulinism
Congenital Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Hypoglycemia

ClinicalTrials.gov processed this record on September 22, 2014