A Retrospective Analysis of Pancreatic Injuries and Treatment Outcomes

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. Does a statistically significant association exist between pancreatic injury grade and the following individual factors:

   • Mortality
   • Morbidity
   • Injury severity score
2. Is there an association between post-operative pancreatic complications and operation-specific intervention?
3. 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 Overview

• Status: Completed
• Conditions: Anastomotic Leak; Intra-Abdominal Abscess; Pancreas Injury; Pancreas Cyst; Pancreas Necrosis; Pancreas; Fistula; Pancreatic Trauma; Pancreatic Duct Injury; Pancreas Abscess
• Intervention / Treatment: Procedure: Exploratory laparotomy

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93306
      • Kern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• history of pancreatic surgery
• Iatrogenic pancreatic injuries

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Penetrating intra-abdominal injury; Patients diagnosed with a pancreatic injury secondary to penetrating intra-abdominal injury subdivided by pancreatic injury grade	Procedure: Exploratory laparotomy; 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.
Blunt intra-abdominal injury; Patients diagnosed with a pancreatic injury secondary to blunt intra-abdominal injury subdivided by pancreatic injury grade	Procedure: Exploratory laparotomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication occurrence	Complications including wound dehiscence, pancreatic duct leak, pancreatic pseudocyst, pancreatic fistula formation, pancreatic necrosis, intra-abdominal abscess, traumatic pancreatitis, anastomotic leak	Up to 12 weeks postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Associated intra-abdominal injuries	concomitant intra-abdominal injuries including pancreatic duck, diaphragm, stomach, liver, kidney, Major vasculature, spleen, duodenum, small bowel, colon, ureter	within 48 hours of admission

Collaborators and Investigators

• Sponsor: Kern Medical Center
• Investigators: Principal Investigator: Amber Jones, DO, MPH, Kern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Estimated): January 29, 2024

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pancreatic trauma; Penetrating abdominal injury; Abdominal trauma
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Neoplasms; Inflammation; Postoperative Complications; Cysts; Pathological Conditions, Anatomical; Suppuration; Pancreatic Diseases; Digestive System Fistula; Wounds and Injuries; Fistula; Abscess; Necrosis; Anastomotic Leak; Abdominal Abscess; Pancreatic Fistula; Pancreatic Cyst
• Other Study ID Numbers: 11894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No