Non-focal Congenital Hyperinsulinismnon-focal CHINCT02108730
Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism
An observational study of Non-focal Congenital Hyperinsulinism, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
Observational study in patients with non-focal congenital hyperinsulinism showing that restrictive surgery may improve the metabolic situation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-focal Congenital Hyperinsulinism
- What is being tested?
- restrictive pancreatic resection
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 13 children and one adult (30 years)
Who may be able to join
- patients with non-focal congenital hyperinsulinism
Who cannot join
- patients with focal congenital hyperinsulinism
Trial locations and contacts
1 site in 1 country.
About this study
Observational study in patients with non-focal congenital hyperinsulinism showing that restrictive surgery may improve the metabolic situation
Read the 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.
- Conditions
- Non-focal Congenital Hyperinsulinism
- Being tested
- restrictive pancreatic resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restrictive pancreatic resectionProcedure or surgery
Restrictive, spleen-preserving resection of the pancreatic tail by laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| non-focal congenital hyperinsulinism | 13 children and one adult with non-focal congenital hyperinsulinism Receives: Procedure: restrictive pancreatic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
necessity of medication after restrictive surgery in congenital hyperinsulinism
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startMar 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-focal Congenital HyperinsulinismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Winfried Barthlen, University Medicine Greifswald
- Investigators
- Winfried Barthlen, Professor of Pediatric Surgery, Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108730
- Sponsor's protocol ID
- 123456
- Acronym
- non-focal CHI
- Status last verified
- Apr 2014
- First submitted
- 28 Mar 2014
- Last updated
- 9 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism
- ClinicalTrials.gov ID
- NCT02108730
- Acronym / sponsor ID
- non-focal CHI / 123456
- Conditions
- Non-focal Congenital Hyperinsulinism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-focal congenital hyperinsulinism | – | Procedure: restrictive pancreatic resection13 children and one adult with non-focal congenital hyperinsulinism |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 13 children and one adult (30 years)
Key inclusion criteria (1 listed)
- patients with non-focal congenital hyperinsulinism
Key exclusion criteria (1 listed)
- patients with focal congenital hyperinsulinism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| restrictive pancreatic resectionRestrictive, spleen-preserving resection of the pancreatic tail by laparoscopy | Procedure or surgery | non-focal congenital hyperinsulinism |
Primary outcome
necessity of medication after restrictive surgery in congenital hyperinsulinism
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried Barthlen, Professor of Pediatric Surgery principal investigator
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-focal Congenital Hyperinsulinism, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
necessity of medication after restrictive surgery in congenital hyperinsulinism (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.