Pancreatic TraumaNCT06227871
A Retrospective Analysis of Pancreatic Injuries and Treatment Outcomes
An observational study of Pancreatic Trauma and Pancreatic Duct Injury, run by Kern Medical Center at 1 site in United States.
Trial summary
The goal of this observational study is to compare the presentation, treatment, and outcomes in patients suffering traumatic pancreatic injuries from blunt or penetrating trauma. The questions this study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Trauma, Pancreatic Duct Injury, Pancreas Necrosis
- What is being tested?
- Exploratory laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 1 Mar 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient's greater than 18 years old, with no history of pancreatic surgery who were hospitalized at Kern Medical Center from November 1st, 2019 to March 1st, 2023 after presenting to the institution's emergency department as tier 1 and 2 trauma activations following blunt or penetrating abdominal injury and were diagnosed with pancreatic injury during the same hospitalization.
Who may be able to join
- Hospitalized at Kern Medical Center after presenting to the institution's emergency department as a tier 1 and 2 trauma activation
- Hospitalized following blunt or penetrating abdominal injury
- Diagnosed with traumatic pancreatic injury during same admission
Who cannot join
- history of pancreatic surgery
- Iatrogenic pancreatic injuries
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to compare the presentation, treatment, and outcomes in patients suffering traumatic pancreatic injuries from blunt or penetrating trauma.
The questions this study aims to answer are:
Read more
- Does a statistically significant association exist between pancreatic injury grade and the following individual factors:
- Mortality
- Morbidity
- Injury severity score
- Is there an association between post-operative pancreatic complications and operation-specific intervention?
- Does pancreatic injury score correlate with certain intra-abdominal organ injuries?
Participants meeting criteria are greater than 18 years old, with no history of pancreatic surgery who were hospitalized at Kern Medical Center after presenting to the institution's emergency department as tier 1 or 2 trauma activations following blunt or penetrating abdominal injury and were diagnosed with pancreatic injury during the same hospitalization.
- Conditions
- Pancreatic Trauma, Pancreatic Duct Injury, Pancreas Necrosis, Pancreas Cyst, Pancreas; Fistula, Pancreas Abscess
- Being tested
- Exploratory laparotomy
- Keywords
- Pancreatic trauma, Penetrating abdominal injury, Abdominal trauma
- Medical subject headings
- Pancreatitis, Acute Necrotizing, Pancreatic Cyst, Pancreatic Fistula, Abdominal Abscess, Anastomotic Leak, Abdominal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exploratory laparotomyProcedure or surgery
Exploratory laparotomy with interventions addressing pancreatic injuries Grade 1-5 including pancreatic interventions including subtotal pancreatectomy, distal pancreatectomy, pancreatic ligation, pyloric diversion, or simple drainage of the pancreas.
| Study group | Role | What they receive |
|---|---|---|
| Penetrating intra-abdominal injury | Patients diagnosed with a pancreatic injury secondary to penetrating intra-abdominal injury subdivided by pancreatic injury grade Receives: Procedure: Exploratory laparotomy | |
| Blunt intra-abdominal injury | Patients diagnosed with a pancreatic injury secondary to blunt intra-abdominal injury subdivided by pancreatic injury grade Receives: Procedure: Exploratory laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication occurrence
Complications including wound dehiscence, pancreatic duct leak, pancreatic pseudocyst, pancreatic fistula formation, pancreatic necrosis, intra-abdominal abscess, traumatic pancreatitis, anastomotic leak
Measured: Up to 12 weeks postoperatively
Secondary outcomes (1)
Associated intra-abdominal injuries
concomitant intra-abdominal injuries including pancreatic duck, diaphragm, stomach, liver, kidney, Major vasculature, spleen, duodenum, small bowel, colon, ureter
Measured: within 48 hours of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Nov 2019
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic TraumaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amber Jones, Kern Medical Center
- Investigators
- Amber Jones, DO, MPH, Principal investigator, Kern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227871
- Sponsor's protocol ID
- 11894
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 29 Jan 2024
- 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 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Pancreatic Injuries and Treatment Outcomes
- ClinicalTrials.gov ID
- NCT06227871
- Acronym / sponsor ID
- 11894
- Conditions
- Pancreatic Trauma, Pancreatic Duct Injury, Pancreas Necrosis, Pancreas Cyst, Pancreas; Fistula, Pancreas Abscess
- Keywords
- Pancreatic trauma, Penetrating abdominal injury, Abdominal trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Kern Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 29 Jan 2024 (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.
The goal of this observational study is to compare the presentation, treatment, and outcomes in patients suffering traumatic pancreatic injuries from blunt or penetrating trauma.
The questions this study aims to answer are:
- Does a statistically significant association exist between pancreatic injury grade and the following individual factors:
- Mortality
- Morbidity
- Injury severity score
- Is there an association between post-operative pancreatic complications and operation-specific intervention?
- Does pancreatic injury score correlate with certain intra-abdominal organ injuries?
Participants meeting criteria are greater than 18 years old, with no history of pancreatic surgery who were hospitalized at Kern Medical Center after presenting to the institution's emergency department as tier 1 or 2 trauma activations following blunt or penetrating abdominal injury and were diagnosed with pancreatic injury during the same hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Penetrating intra-abdominal injury | – | Procedure: Exploratory laparotomyPatients diagnosed with a pancreatic injury secondary to penetrating intra-abdominal injury subdivided by pancreatic injury grade |
| Blunt intra-abdominal injury | – | Procedure: Exploratory laparotomyPatients diagnosed with a pancreatic injury secondary to blunt intra-abdominal injury subdivided by pancreatic injury grade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient's greater than 18 years old, with no history of pancreatic surgery who were hospitalized at Kern Medical Center from November 1st, 2019 to March 1st, 2023 after presenting to the institution's emergency department as tier 1 and 2 trauma activations following blunt or penetrating abdominal injury and were diagnosed with pancreatic injury during the same hospitalization.
Key inclusion criteria (3 listed)
- Hospitalized at Kern Medical Center after presenting to the institution's emergency department as a tier 1 and 2 trauma activation
- Hospitalized following blunt or penetrating abdominal injury
- Diagnosed with traumatic pancreatic injury during same admission
Key exclusion criteria (2 listed)
- history of pancreatic surgery
- Iatrogenic pancreatic injuries
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 |
|---|---|---|
| Exploratory laparotomyExploratory laparotomy with interventions addressing pancreatic injuries Grade 1-5 including pancreatic interventions including subtotal pancreatectomy, distal pancreatectomy, pancreatic ligation, pyloric diversion, or simple drainage of the pancreas. | Procedure or surgery | Blunt intra-abdominal injury, Penetrating intra-abdominal injury |
Primary outcome
Complication occurrence
Time frame: Up to 12 weeks postoperatively
Complications including wound dehiscence, pancreatic duct leak, pancreatic pseudocyst, pancreatic fistula formation, pancreatic necrosis, intra-abdominal abscess, traumatic pancreatitis, anastomotic leak
1 secondary outcome
Associated intra-abdominal injuries
Time frame: within 48 hours of admission
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 29 Jan 2024.
- 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.
Amber Jones, DO, MPH principal investigator
Kern Medical Center
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 Trauma and Pancreatic Duct Injury, run by Kern Medical Center at 1 site in United States.
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 3 inclusion and 2 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 29 Jan 2024. 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 United States. 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?
Complication occurrence (time frame: Up to 12 weeks postoperatively). 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 29 Jan 2024.