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NCT04016506 Clinical Trial

Epidemiology, Management and Complications Related to Pancreatic Trauma in Children

Child, Only Clinical Trial

— PANC-TRAUMA  

Official title:
Retrospective and Prospective Study on the Epidemiology, Management and Complications Related to Pancreatic Trauma in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04016506
Other study ID # 2018/18OCT/394
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 15, 2019
Est. completion date September 15, 2021

Study information
Verified date July 2019
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact Isabelle Scheers, MD, PhD
Phone +3227646007
Email isabelle.scheers@uclouvain.be
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date September 15, 2021
Est. primary completion date September 15, 2021
Accepts healthy volunteers
Gender All
Age group N/A to 17 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• nutritional questionnaire
nutritional questionnaire is given to the patient after the injury

Locations
Country Name City State
Belgium Cliniques universitaires Saint-Luc Bruxelles
Belgium Erasme/HUDERF Bruxelles
Belgium ULG La Citadelle Liège

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of pancreas injury in children number of new diagnosis from start of inclusion to 2 years thereafter
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