A Retrospective Analysis Of Pancreatic Injuries And Treatment Outcomes

Study Overview

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.

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Pancreatic Trauma
Pancreatic Duct Injury
Pancreas Necrosis
Pancreas Cyst
Pancreas; Fistula
Pancreas Abscess
Intra-Abdominal Abscess
Anastomotic Leak
Pancreas Injury

PROCEDURE: Exploratory laparotomy

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Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-01-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-01-25
First Submitted that Met QC Criteria 2024-01-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-01-29
First Posted (ACTUAL) 2024-01-29	Results First Posted N/A	Last Verified 2024-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
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Allocation:
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Interventional Model:
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Masking:
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Arms and Interventions

Participant Group/Arm	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.

Participant Group/Arm

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.

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

history of pancreatic surgery
Iatrogenic pancreatic injuries

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Amber Jones, DO, MPH, Kern Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record