A Retrospective Analysis of Pancreatic Injuries and Treatment Outcomes

Anastomotic Leak Clinical Trial

Official title:

A Retrospective Analysis of Pancreatic Injuries and Treatment Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06227871
• Other study ID #: 11894
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: March 1, 2023

Study information

• Verified date: January 2024
• Source: Kern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Abscess
• Abscess
• Anastomotic Leak
• Fistula
• Intra-Abdominal Abscess
• Necrosis
• Pancreas Cyst
• Pancreas Injury
• Pancreas Necrosis
• Pancreas; Fistula
• Pancreatic Cyst
• Pancreatic Fistula
• Pancreatic Trauma
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Kern Medical Center	Bakersfield	California

Sponsors (1)

Lead Sponsor	Collaborator
Kern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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