EmergenciesNCT05139394
Emergency Pancreaticoduodenectomy: a Non-trauma Center Case Series
An observational study of Emergencies and Pancreas Disease, run by Iuliu Hatieganu University of Medicine and Pharmacy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies, Pancreas Disease
- What is being tested?
- emergency pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated in Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor Cluj-Napoca January 2014 and May 2021
Who may be able to join
- Emergency pancreaticoduodenectomy performed
Who cannot join
- Elective surgery
- Insufficient data
About this study
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.
- Conditions
- Emergencies, Pancreas Disease
- Being tested
- emergency pancreaticoduodenectomy
- Medical subject headings
- Emergencies, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emergency pancreaticoduodenectomyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
ml of blood
Measured: The length of the surgical intervention (an average of 3 hours)
Operative time
minutes of operating time
Measured: The length of the surgical intervention (an average of 3 hours)
In-hospital Morbidity
Measured: Up to 90 days. Through study completion, during the hospital admission period
In-hospital Mortality
Measured: 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
Measured: The date of the last follow-up information was August 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study startJan 2014
- Primary completionSep 2021
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Schlanger, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139394
- Sponsor's protocol ID
- EPD - CS
- Status last verified
- Nov 2021
- First submitted
- 29 Sep 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Pancreaticoduodenectomy: a Non-trauma Center Case Series
- ClinicalTrials.gov ID
- NCT05139394
- Acronym / sponsor ID
- EPD - CS
- Conditions
- Emergencies, Pancreas Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated in Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor Cluj-Napoca January 2014 and May 2021
Key inclusion criteria (1 listed)
- Emergency pancreaticoduodenectomy performed
Key exclusion criteria (2 listed)
- Elective surgery
- Insufficient data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| emergency pancreaticoduodenectomyEmergency 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. | Procedure or surgery | – |
Primary outcome
Intraoperative blood loss
Time frame: The length of the surgical intervention (an average of 3 hours)
ml of blood
Operative time
Time frame: The length of the surgical intervention (an average of 3 hours)
minutes of operating time
In-hospital Morbidity
Time frame: Up to 90 days. Through study completion, during the hospital admission period
In-hospital Mortality
Time frame: Up to 90 days. Through study completion, during the hospital admission period
Long-term evolution
Time frame: The date of the last follow-up information was August 2021
It will be measured the overall survival time, number of readmissions and number of reinterventions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies and Pancreas Disease, run by Iuliu Hatieganu University of Medicine and Pharmacy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: The length of the surgical intervention (an average of 3 hours)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.