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OpenTrials
Completed

NCT Number: NCT06227871

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exploratory laparotomy

Procedure

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 outcomes

  1. 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

Secondary outcomes

  1. Associated intra-abdominal injuries

    Time frame: within 48 hours of admission

    concomitant intra-abdominal injuries including pancreatic duck, diaphragm, stomach, liver, kidney, Major vasculature, spleen, duodenum, small bowel, colon, ureter

Sponsors and collaborators

Lead sponsor

Kern Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 29, 2024
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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