NCT05139394

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

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

January 1, 2014

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

7.7 years

First QC Date

September 29, 2021

Last Update Submit

November 30, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Emergency pancreaticoduodenectomy performed

You may not qualify if:

  • Elective surgery
  • Insufficient data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

EmergenciesPancreatic Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2021

First Posted

December 1, 2021

Study Start

January 1, 2014

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

December 1, 2021

Record last verified: 2021-11