Towards Individualized Surgery in Non-focal Congenital Hy... | NCT02108730

Studies
Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism

NCT02108730

Sponsor

University Medicine Greifswald

Status

Completed

Last Update Posted

Apr 9, 2014Estimated

Enrollment

14Actual

Phase

Not provided

Conditions

Non-focal Congenital Hyperinsulinism

Interventions

restrictive pancreatic resection

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Mar 28, 2014

First Submission Date that Met QC Criteria

Apr 8, 2014

First Posted Date

Apr 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2014

Last Update Posted Date

Apr 9, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Winfried Barthlen, Professor of Pediatric surgery, University Medicine GreifswaldPrincipal Investigator

Lead Sponsor

University Medicine GreifswaldOTHER

Collaborators

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non-focal congenital hyperinsulinism		13 children and one adult with non-focal congenital hyperinsulinism	Procedure: restrictive pancreatic resection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
restrictive pancreatic resection	Procedure	Restrictive, spleen-preserving resection of the pancreatic tail by laparoscopy	non-focal congenital hyperinsulinism

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with non-focal congenital hyperinsulinism

Exclusion Criteria:

patients with focal congenital hyperinsulinism

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

13 children and one adult (30 years)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Winfried Barthlen, Professor of Pediatric Surgery	University Medicine Greifswald	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Surgery		Greifswald		D-17475	Germany