Serum Lipase and Severity of Pancreatic Injury.

NCT05978076 | Completed

• 1 other identifier: IRBN472021/CHUSTE
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Injury

Keywords

Lipase; Pancreatic trauma; Pseudocysts

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Local complications

  Month: 9 (end of study)

• Maximal lipase level

  Month: 9 (end of study)

Study Arms (1)

Every children with elevated serum lipase

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

Other: data collection

Interventions

data collection OTHER

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

Every children with elevated serum lipase

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Elevation of lipase secondary to pancreatic tumor

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Aurélien SCALABRE, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 7, 2023
• Study Start: December 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: August 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)