NCT06227871

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:

  • 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

3.3 years

First QC Date

January 17, 2024

Last Update Submit

January 25, 2024

Conditions

Pancreatic TraumaPancreatic Duct InjuryPancreas NecrosisPancreas CystPancreas; FistulaPancreas AbscessIntra-Abdominal AbscessAnastomotic LeakPancreas Injury

Keywords

Pancreatic traumaPenetrating abdominal injuryAbdominal trauma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Associated intra-abdominal injuries

    within 48 hours of admission

Study Arms (2)

Penetrating intra-abdominal injury

Patients diagnosed with a pancreatic injury secondary to penetrating intra-abdominal injury subdivided by pancreatic injury grade

Procedure: Exploratory laparotomy

Blunt intra-abdominal injury

Patients diagnosed with a pancreatic injury secondary to blunt intra-abdominal injury subdivided by pancreatic injury grade

Procedure: Exploratory laparotomy

Interventions

Exploratory laparotomyPROCEDURE

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 injuryPenetrating intra-abdominal injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • history of pancreatic surgery
  • Iatrogenic pancreatic injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kern Medical Center

Bakersfield, California, 93306, United States

Location

MeSH Terms

Conditions

Pancreatitis, Acute NecrotizingPancreatic CystPancreatic FistulaAbdominal AbscessAnastomotic LeakAbdominal Injuries

Interventions

Laparotomy

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesCystsNeoplasmsDigestive System FistulaFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsAbscessSuppurationInfectionsPostoperative ComplicationsPathologic ProcessesWounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Amber Jones, DO, MPH

    Kern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, DO, MPH

Study Record Dates

First Submitted

January 17, 2024

First Posted

January 29, 2024

Study Start

November 1, 2019

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)