NCT04016506

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

July 9, 2019

Last Update Submit

July 9, 2019

Conditions

Pancreas InjuryChild, Only

Keywords

Pancreas InjuryChild

Outcome Measures

Primary Outcomes (1)

  • incidence of pancreas injury in children

    number of new diagnosis

    from start of inclusion to 2 years thereafter

Study Arms (1)

Pancreas injury

children with Pancreas trauma

Other: nutritional questionnaire

Interventions

nutritional questionnaireOTHER

nutritional questionnaire is given to the patient after the injury

Pancreas injury

Eligibility Criteria

AgeUp to 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • age \>18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Erasme/HUDERF

Brussels, Belgium

Location

ULG La Citadelle

Liège, 4000, Belgium

Location

Study Officials

  • Isabelle Scheers, MD, PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Scheers, MD, PhD

CONTACT

+3227646007isabelle.scheers@uclouvain.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 11, 2019

Study Start

September 15, 2019

Primary Completion

September 15, 2021

Study Completion

September 15, 2021

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(3)