Serum Lipase and Severity of Pancreatic Injury.

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: Pancreatic Injury
• Intervention / Treatment: Other: data collection

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

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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)	Collected in medical history.	Month: 9 (end of study)
lipase level in light pancreatic injury (without duct injury)	Collected in medical history.	Month: 9 (end of study)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Aurélien SCALABRE, MD, CHU Saint-Etienne

Study record dates

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: Lipase; Pancreatic trauma; Pseudocysts
• Additional Relevant MeSH Terms: Wounds and Injuries
• 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