Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism

Completed

• Conditions: Non-focal Congenital Hyperinsulinism
• Interventions: Procedure: restrictive pancreatic resection

• Registration Number: NCT02108730
• Lead Sponsor: University Medicine Greifswald

Brief Summary

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

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 Timeline

• Study Start: 2011-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted: 2014-03-28
• Status Verified: 2014-04
• Study First Submitted QC: 2014-04-08
• Last Update Submitted: 2014-04-08
• Study First Posted: 2014-04-09
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• patients with non-focal congenital hyperinsulinism

Exclusion Criteria

• patients with focal congenital hyperinsulinism

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-focal congenital hyperinsulinism	restrictive pancreatic resection	13 children and one adult with non-focal congenital hyperinsulinism

Primary Outcome Measures

Name	Time	Method
necessity of medication after restrictive surgery in congenital hyperinsulinism	up to 3 years

Trial Locations

Locations (1)

Pediatric Surgery; 🇩🇪 Greifswald, Germany