A Retrospective Analysis of Pancreatic Injuries and Treatment Outcomes

Completed

• Conditions: Pancreatic Trauma; Pancreas Necrosis; Pancreas; Fistula; Pancreatic Duct Injury; Anastomotic Leak; Pancreas Injury; Intra-Abdominal Abscess; Pancreas Cyst; Pancreas Abscess
• Interventions: Procedure: Exploratory laparotomy

• Registration Number: NCT06227871
• Lead Sponsor: Kern Medical Center

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blunt intra-abdominal injury	Exploratory laparotomy	Patients diagnosed with a pancreatic injury secondary to blunt intra-abdominal injury subdivided by pancreatic injury grade
Penetrating intra-abdominal injury	Exploratory laparotomy	Patients diagnosed with a pancreatic injury secondary to penetrating intra-abdominal injury subdivided by pancreatic injury grade

Primary Outcome Measures

Name	Time	Method
Complication occurrence	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kern Medical Center; 🇺🇸 Bakersfield, California, United States