Pancreas InjuryPANC-TRAUMANCT04016506
Epidemiology, Management and Complications Related to Pancreatic Trauma in Children
An observational study of Pancreas Injury and Child, Only, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 3 sites in Belgium.
Trial summary
The aim of this study is to better evaluate the treatment and development of children and adolescents who have had a pancreatic trauma and who are being followed in Belgian hospitals. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pancreas Injury, Child, Only
- What is being tested?
- nutritional questionnaire
- How many people
- 150 participants
- Where
- 3 sitesBelgium
- Study dates
- 15 Sep 2019to 15 Sep 2021
- 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 Up to 17 years
- All sexes
- Child
Study population: * Child aged ˂18 years at the time of the trauma * Child regularly followed in paediatric gastroenterology consultation * Positive history of pancreatic trauma * Child with at least one blood lipase measurement * Child with at least one pancreatic imaging available
Who may be able to join
- Child aged ˂18 years at the time of the trauma
- Child regularly followed in paediatric gastroenterology consultation
- Positive history of pancreatic trauma
- Child with at least one blood lipase measurement
- Child with at least one pancreatic imaging available
Who cannot join
- age >18 years
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Cliniques universitaires Saint-Luc
Brussels, 1200
Isabelle Scheers, MD, PhD, isabelle.scheers@uclouvain.be
Erasme/HUDERF
Brussels
Myriam Delhaye, MD
Myriam Delhaye, MD
ULG La Citadelle
Liège, 4000
Angélique Lhomme, MD
Angélique Lhomme, MD
About this study
Official title: Retrospective and Prospective Study on the Epidemiology, Management and Complications Related to Pancreatic Trauma in Children
The aim of this study is to better evaluate the treatment and development of children and adolescents who have had a pancreatic trauma and who are being followed in Belgian hospitals.
Read the detailed description
The aim of this study is to better evaluate the treatment and development of children and adolescents who have had a pancreatic trauma and who are being followed in Belgian hospitals.
Through this study, the investigators hope to be able to understand:
- The epidemiology of pancreatic trauma in Belgium. How these traumas occur (accident, fall,...).
- Pancreatic trauma management in Belgian hospitals according to severity grade.
- Short- and medium-term complications associated with the trauma
- Long-term complications of trauma on growth and on the endocrine and exocrine function of the pancreas.
On the basis of all the information collected, the investigators hope to be able to provide indicators on the epidemiology of pancreatic trauma in children, short-term risks as well as nutritional and functional risks, taking into account the initial management of the patient.
- Conditions
- Pancreas Injury, Child, Only
- Being tested
- nutritional questionnaire
- Keywords
- Pancreas Injury, Child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional questionnaireOther
nutritional questionnaire is given to the patient after the injury
| Study group | Role | What they receive |
|---|---|---|
| Pancreas injury | children with Pancreas trauma Receives: Other: nutritional questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of pancreas injury in children
number of new diagnosis
Measured: from start of inclusion to 2 years thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start15 Sep 2019 (estimated)
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas InjuryStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Scheers, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016506
- Sponsor's protocol ID
- 2018/18OCT/394
- Acronym
- PANC-TRAUMA
- Status last verified
- Jul 2019
- First submitted
- 9 Jul 2019
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Study on the Epidemiology, Management and Complications Related to Pancreatic Trauma in Children
- ClinicalTrials.gov ID
- NCT04016506
- Acronym / sponsor ID
- PANC-TRAUMA / 2018/18OCT/394
- Conditions
- Pancreas Injury, Child, Only
- Keywords
- Pancreas Injury, Child
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 Sep 2019 (estimated)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 11 Jul 2019 (actual)
- 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.
The aim of this study is to better evaluate the treatment and development of children and adolescents who have had a pancreatic trauma and who are being followed in Belgian hospitals.
Detailed description
The aim of this study is to better evaluate the treatment and development of children and adolescents who have had a pancreatic trauma and who are being followed in Belgian hospitals.
Through this study, the investigators hope to be able to understand:
- The epidemiology of pancreatic trauma in Belgium. How these traumas occur (accident, fall,...).
- Pancreatic trauma management in Belgian hospitals according to severity grade.
- Short- and medium-term complications associated with the trauma
- Long-term complications of trauma on growth and on the endocrine and exocrine function of the pancreas.
On the basis of all the information collected, the investigators hope to be able to provide indicators on the epidemiology of pancreatic trauma in children, short-term risks as well as nutritional and functional risks, taking into account the initial management of the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreas injury | – | Other: nutritional questionnairechildren with Pancreas trauma |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- * Child aged ˂18 years at the time of the trauma * Child regularly followed in paediatric gastroenterology consultation * Positive history of pancreatic trauma * Child with at least one blood lipase measurement * Child with at least one pancreatic imaging available
Key inclusion criteria (5 listed)
- Child aged ˂18 years at the time of the trauma
- Child regularly followed in paediatric gastroenterology consultation
- Positive history of pancreatic trauma
- Child with at least one blood lipase measurement
- Child with at least one pancreatic imaging available
Key exclusion criteria (1 listed)
- age >18 years
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 |
|---|---|---|
| nutritional questionnairenutritional questionnaire is given to the patient after the injury | Other | Pancreas injury |
Primary outcome
incidence of pancreas injury in children
Time frame: from start of inclusion to 2 years thereafter
number of new diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Isabelle Scheers, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Injury and Child, Only, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 3 sites in Belgium.
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 5 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: status not confirmed, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Scheers, MD, PhD (+3227646007, isabelle.scheers@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of pancreas injury in children (time frame: from start of inclusion to 2 years thereafter). 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 11 Jul 2019.