Serum Lipase and Severity of Pancreatic Injury.

Completed

• Conditions: Pancreatic Injury
• Interventions: Other: data collection

• Registration Number: NCT05978076
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

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 Timeline

• Study Start: 2021-12-01
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2023-07
• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-03
• Last Update Submitted: 2023-08-03
• Study First Posted: 2023-08-07
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Every children with elevated serum lipase	data collection	Every children with elevated serum lipase after trauma during those years will be included.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maximal lipase level	Month: 9 (end of study)	Collected in medical history.
Local complications	Month: 9 (end of study)	Collected in medical history.

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France