Pancreatic InjuryNCT05978076
Serum Lipase and Severity of Pancreatic Injury.
An observational study of Pancreatic Injury, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Pancreatic Injury
- What is being tested?
- data collection
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children under 15 years 3 months with elevated lipase serum level after trauma will be included.
Who may be able to join
- Children under 15 years 3 months with elevated lipase serum level after trauma.
Who cannot join
- Elevation of lipase secondary to pancreatic tumor
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Pancreatic Injury
- Being tested
- data collection
- Keywords
- Lipase, Pancreatic trauma, Pseudocysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
data collection : mechanism of injury, associated injury, length of stay, maximal lipase level, nutritional care and local complications.
| Study group | Role | What they receive |
|---|---|---|
| Every children with elevated serum lipase | Every children with elevated serum lipase after trauma during those years will be included. Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
lipase level in severe pancreatic injury (duct injury)
Collected in medical history.
Measured: Month: 9 (end of study)
lipase level in light pancreatic injury (without duct injury)
Collected in medical history.
Measured: Month: 9 (end of study)
Secondary outcomes (2)
Local complications
Collected in medical history.
Measured: Month: 9 (end of study)
Maximal lipase level
Collected in medical history.
Measured: Month: 9 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Dec 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélien SCALABRE, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978076
- Sponsor's protocol ID
- IRBN472021/CHUSTE
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Lipase and Severity of Pancreatic Injury.
- ClinicalTrials.gov ID
- NCT05978076
- Acronym / sponsor ID
- IRBN472021/CHUSTE
- Conditions
- Pancreatic Injury
- Keywords
- Lipase, Pancreatic trauma, Pseudocysts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Every children with elevated serum lipase | – | Other: data collectionEvery children with elevated serum lipase after trauma during those years will be included. |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under 15 years 3 months with elevated lipase serum level after trauma will be included.
Key inclusion criteria (1 listed)
- Children under 15 years 3 months with elevated lipase serum level after trauma.
Key exclusion criteria (1 listed)
- Elevation of lipase secondary to pancreatic tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectiondata collection : mechanism of injury, associated injury, length of stay, maximal lipase level, nutritional care and local complications. | Other | Every children with elevated serum lipase |
Primary outcome
lipase level in severe pancreatic injury (duct injury)
Time frame: Month: 9 (end of study)
Collected in medical history.
lipase level in light pancreatic injury (without duct injury)
Time frame: Month: 9 (end of study)
Collected in medical history.
2 secondary outcomes
Local complications
Time frame: Month: 9 (end of study)
Maximal lipase level
Time frame: Month: 9 (end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélien SCALABRE, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Injury, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lipase level in severe pancreatic injury (duct injury) (time frame: Month: 9 (end of study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.