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Completed

NCT Number: NCT02108730

Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism

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

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Key information

Conditions

Non-focal Congenital Hyperinsulinism

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Surgery

Greifswald, D-17475, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with non-focal congenital hyperinsulinism

Exclusion criteria

  • patients with focal congenital hyperinsulinism

Treatment and study plan

restrictive pancreatic resection

Procedure

Restrictive, spleen-preserving resection of the pancreatic tail by laparoscopy

Primary outcomes

  1. necessity of medication after restrictive surgery in congenital hyperinsulinism

    Time frame: up to 3 years

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Acronym: non-focal CHI

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
Apr 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.