Serum Lipase and Severity of Pancreatic Injury.

August 3, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

Diagnosis of pancreas injury is not easy at first consult. It's a retrospective study, in children under 15 years and 3months, between January 1st 2010 to August 31th 2019, to prove that the first level of lipase is correlated with the severity of pancreatic injury.

Every children with elevated serum lipase after trauma during those years will be selected.

The children with pancreatic tumors will be excluded. American Association of Surgeon Trauma (AAST) classification of pancreas injury will be used to grade severity.

Children will be divided in two groups : one including pancreatic lesion with duct injury and one without duct injury.

Data will include mechanism of injury, associated injury, length of stay, maximal lipase level, nutritional care and local complications will be noted.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective of this study is to determine if there is a correlation between the initial serum lipase and the severity of the pancreatic injury.

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

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

Study Locations

  • France
      • Saint-Étienne, France
        • CHU Saint-étienne

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

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children under 15 years 3 months with elevated lipase serum level after trauma will be included.

Description

Inclusion Criteria:

  • Children under 15 years 3 months with elevated lipase serum level after trauma.

Exclusion Criteria:

  • Elevation of lipase secondary to pancreatic tumor

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Every children with elevated serum lipase
Every children with elevated serum lipase after trauma during those years will be included.
Other: data collection
data collection : mechanism of injury, associated injury, length of stay, maximal lipase level, nutritional care and local complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lipase level in severe pancreatic injury (duct injury)
Time Frame: Month: 9 (end of study)
Collected in medical history.
Month: 9 (end of study)
lipase level in light pancreatic injury (without duct injury)
Time Frame: Month: 9 (end of study)
Collected in medical history.
Month: 9 (end of study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local complications
Time Frame: Month: 9 (end of study)
Collected in medical history.
Month: 9 (end of study)
Maximal lipase level
Time Frame: Month: 9 (end of study)
Collected in medical history.
Month: 9 (end of study)

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Aurélien SCALABRE, MD, CHU Saint-étienne

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 (Actual)

December 1, 2021

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN472021/CHUSTE

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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