Epidemiology, Management and Complications Related to Pan... | NCT04016506

Studies
Epidemiology, Management and Complications Related to Pancreatic Trauma in Children

NCT04016506

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Unknown status

Last Update Posted

Jul 11, 2019Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Pancreas Injury
Child, Only

Interventions

nutritional questionnaire

Countries

Belgium

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

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2019Estimated

Primary Completion Date

Sep 15, 2021Estimated

Completion Date

Sep 15, 2021Estimated

First Submitted Date

Jul 9, 2019

First Submission Date that Met QC Criteria

Jul 9, 2019

First Posted Date

Jul 11, 2019Actual

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

Jul 9, 2019

Last Update Posted Date

Jul 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

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

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pancreas injury		children with Pancreas trauma	Other: nutritional questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nutritional questionnaire	Other	nutritional questionnaire is given to the patient after the injury	Pancreas injury

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of pancreas injury in children	number of new diagnosis	from start of inclusion to 2 years thereafter

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

age >18 years

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Years

Standard Ages

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Isabelle Scheers, MD, PhD	Contact	+3227646007		isabelle.scheers@uclouvain.be

Overall Officials

Name	Affiliation	Role
Isabelle Scheers, MD, PhD	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques universitaires Saint-Luc		Brussels		1200	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided