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

April 8, 2014 updated by: Prof. Winfried Barthlen, University Medicine Greifswald
Observational study in patients with non-focal congenital hyperinsulinism showing that restrictive surgery may improve the metabolic situation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Greifswald, Germany, D-17475
        • Pediatric Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

13 children and one adult (30 years)

Description

Inclusion Criteria:

  • patients with non-focal congenital hyperinsulinism

Exclusion Criteria:

  • patients with focal congenital hyperinsulinism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
necessity of medication after restrictive surgery in congenital hyperinsulinism
Time Frame: up to 3 years
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Investigators

  • Principal Investigator: Winfried Barthlen, Professor of Pediatric Surgery, University Medicine Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 9, 2014

Study Record Updates

Last Update Posted (Estimate)

April 9, 2014

Last Update Submitted That Met QC Criteria

April 8, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123456 (UMMashhad)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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