Emergency Pancreaticoduodenectomy: a Non-trauma Center Case Series

Emergencies Clinical Trial

Official title:

Emergency Pancreaticoduodenectomy: a Non-trauma Center Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05139394
• Other study ID #: EPD - CS
• Status: Completed
• Start date: January 2014
• Est. completion date: September 2021

Study information

• Verified date: November 2021
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pancreaticoduodenectomy is a challenging procedure itself, being even more complex and demanding in emergency settings. Only a few cases of emergency pancreaticoduodenectomy (EPD) are reported in medical literature, usually performed for complex pancreaticoduodenal lesions. EPD has first been mentioned in trauma settings, even fewer cases being reported for non-traumatic indications. The investigators intend to present our experience with this intervention, in a non-trauma surgical centre. Our study is a prospective consecutive case series, that included patients that underwent emergency pancreaticoduodenectomy from January 2014 to May 2021. Data was collected from the electronic system database. The investigators collected data regarding the demographic characteristics of the patients, their medical history, preoperative and postoperative investigations (including blood work and imagistic investigations), surgery related information and postoperative evolution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Emergency pancreaticoduodenectomy performed

Exclusion Criteria:

• Elective surgery
• Insufficient data

Related Conditions & MeSH terms

• Emergencies
• Pancreas Disease
• Pancreatic Diseases

Intervention

Procedure:
• emergency pancreaticoduodenectomy
Emergency pancreaticoduodenectomy (EPD) is a complex surgical procedure, that can be performed for complex pancreaticoduodenal injuries, that cannot be controlled through less invasive procedures. EPD can be performed either as a classical Whipple procedure, or as a pylorus-preserving procedure. A one stage procedure implies the reconstruction step being done in the same surgical intervention, while a two step procedure implies the reconstruction being done in a later stage, through a second surgical intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative blood loss	ml of blood	The length of the surgical intervention (an average of 3 hours)
Primary	Operative time	minutes of operating time	The length of the surgical intervention (an average of 3 hours)
Primary	In-hospital Morbidity		Up to 90 days. Through study completion, during the hospital admission period
Primary	In-hospital Mortality		Up to 90 days. Through study completion, during the hospital admission period
Primary	Long-term evolution	It will be measured the overall survival time, number of readmissions and number of reinterventions	The date of the last follow-up information was August 2021