Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism

Non-focal Congenital Hyperinsulinism Clinical Trial

— non-focal CHI  

Official title:

Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108730
• Other study ID #: 123456
• Status: Completed
• Phase: N/A
• First received: March 28, 2014
• Last updated: April 8, 2014
• Start date: March 2011
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with non-focal congenital hyperinsulinism

Exclusion Criteria:

• patients with focal congenital hyperinsulinism

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Hyperinsulinism
• Hyperinsulinism
• Non-focal Congenital Hyperinsulinism

Intervention

Procedure:
• restrictive pancreatic resection
Restrictive, spleen-preserving resection of the pancreatic tail by laparoscopy

Locations

Country	Name	City	State
Germany	Pediatric Surgery	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	necessity of medication after restrictive surgery in congenital hyperinsulinism		up to 3 years	Yes

External Links

•   homepage of Pediatric Surgery in Greifswald, Germany