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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02108730
First Posted: April 9, 2014
Last Update Posted: April 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Winfried Barthlen, University Medicine Greifswald
  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 Prof. Winfried Barthlen, University Medicine Greifswald:

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

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

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
  Contacts and Locations
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
  More Information

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 Submitted: March 28, 2014
First Posted: April 9, 2014
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