Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism

NCT ID: NCT02108730

Last Updated: 2014-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Non-focal Congenital Hyperinsulinism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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non-focal congenital hyperinsulinism

13 children and one adult with non-focal congenital hyperinsulinism

restrictive pancreatic resection

Intervention Type PROCEDURE

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

Interventions

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restrictive pancreatic resection

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with non-focal congenital hyperinsulinism

Exclusion Criteria

* patients with focal congenital hyperinsulinism
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Prof. Winfried Barthlen

Professor of Pediatric surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Winfried Barthlen, Professor of Pediatric Surgery

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald

Locations

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Pediatric Surgery

Greifswald, , Germany

Site Status

Countries

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Germany

Other Identifiers

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123456

Identifier Type: -

Identifier Source: org_study_id

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