Serum Lipase and Severity of Pancreatic Injury.

Pancreatic Injury Clinical Trial

Official title:

Serum Lipase and Severity of Pancreatic Injury.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05978076
• Other study ID #: IRBN472021/CHUSTE
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Elevation of lipase secondary to pancreatic tumor

Related Conditions & MeSH terms

• Pancreatic Injury
• Wounds and Injuries

Intervention

Other:
• data collection
data collection : mechanism of injury, associated injury, length of stay, maximal lipase level, nutritional care and local complications.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lipase level in severe pancreatic injury (duct injury)	Collected in medical history.	Month: 9 (end of study)
Primary	lipase level in light pancreatic injury (without duct injury)	Collected in medical history.	Month: 9 (end of study)
Secondary	Local complications	Collected in medical history.	Month: 9 (end of study)
Secondary	Maximal lipase level	Collected in medical history.	Month: 9 (end of study)