Epidemiology, Management and Complications Related to Pancreatic Trauma in Children (PANC-TRAUMA)

July 9, 2019 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  1. The epidemiology of pancreatic trauma in Belgium. How these traumas occur (accident, fall,...).
  2. Pancreatic trauma management in Belgian hospitals according to severity grade.
  3. Short- and medium-term complications associated with the trauma
  4. 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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
      • Bruxelles, Belgium
        • Erasme/HUDERF
        • Contact:
          • Myriam Delhaye, MD
        • Principal Investigator:
          • Myriam Delhaye, MD
      • Liège, Belgium, 4000
        • ULG La Citadelle
        • Contact:
          • Angélique Lhomme, MD
        • Principal Investigator:
          • Angélique Lhomme, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pancreas injury
children with Pancreas trauma
Other: nutritional questionnaire
nutritional questionnaire is given to the patient after the injury

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Isabelle Scheers, MD, PhD, Cliniques Universitaires Saint-Luc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 15, 2019

Primary Completion (Anticipated)

September 15, 2021

Study Completion (Anticipated)

September 15, 2021

Study Registration Dates

First Submitted

July 9, 2019

First Submitted That Met QC Criteria

July 9, 2019

First Posted (Actual)

July 11, 2019

Study Record Updates

Last Update Posted (Actual)

July 11, 2019

Last Update Submitted That Met QC Criteria

July 9, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018/18OCT/394

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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