Emergency Pancreaticoduodenectomy: a Non-trauma Center Case Series

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.

Study Overview

• Status: Completed
• Conditions: Emergencies; Pancreas Disease
• Intervention / Treatment: Procedure: emergency pancreaticoduodenectomy

• Study Type: Observational
• Enrollment (Actual): 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients operated in Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor Cluj-Napoca January 2014 and May 2021

Description

Inclusion Criteria:

• Emergency pancreaticoduodenectomy performed

Exclusion Criteria:

• Elective surgery
• Insufficient data

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss	ml of blood	The length of the surgical intervention (an average of 3 hours)
Operative time	minutes of operating time	The length of the surgical intervention (an average of 3 hours)
In-hospital Morbidity		Up to 90 days. Through study completion, during the hospital admission period
In-hospital Mortality		Up to 90 days. Through study completion, during the hospital admission period
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

Collaborators and Investigators

• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Emergencies; Pancreatic Diseases
• Other Study ID Numbers: EPD - CS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No