PancreatectomyNCT06935448
Effect of an Enhanced Recovery After Surgery Program on Outcomes After Pancreatoduodenectomy
An observational study of Pancreatectomy and Enhanced Recovery After Surgery, run by University of Thessaly at 1 site in Greece.
Trial summary
This study assesses whether patients with pancreatic cancer who undergo surgery experience improved outcomes following the implementation of a multidisciplinary care pathway, specifically an enhanced recovery after surgery (ERAS) program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatectomy, Enhanced Recovery After Surgery, Pancreatic Cancer Resectable
- What is being tested?
- enhanced recovery after surgery
- How many people
- 170 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2019to 30 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 undergoing pancreatic surgery in two pancreatic cancer referral centers in central Greece, namely the University Hospital of Larissa, and IASO Thessalias general hospital
Who may be able to join
- adult patients
- diagnosis of pancreatic cancer
- elective open pancreatic surgery
Who cannot join
- age <18 years
- emergency pancreatic surgery
- other surgical procedures
- missing data
- lost to follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ATHINA SAMARA, MD MSc PhD(c) contact
About this study
Official title: Effect of an Enhanced Recovery After Surgery Program on Outcomes After Pancreatoduodenectomy; Experience From Two Referral Centers in Central Greece.
This study assesses whether patients with pancreatic cancer who undergo surgery experience improved outcomes following the implementation of a multidisciplinary care pathway, specifically an enhanced recovery after surgery (ERAS) program.
This pathway includes various interventions in the preoperative, intraoperative, and postoperative care of these patients, all aimed at enhancing their health status and postoperative results.
Read the detailed description
This prospective observational study is conducted by the same surgical team at two high-volume pancreatic cancer referral centers in Greece.
Patients undergoing elective pancreatic surgery are prospectively enrolled and managed according to a standardized ERAS protocol (ERAS group).
A control group, which received standard perioperative care before the implementation of ERAS, was retrospectively selected and matched based on demographic and clinical parameters.
The primary study endpoint is the length of hospital stay (LOS), while secondary endpoints include 30-day mortality and morbidity.
- Being tested
- enhanced recovery after surgery
- Keywords
- pancreatectomy, enhanced recovery after surgery, pancreatic cancer resectable, outcomes research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced recovery after surgeryOther
ERAS group follows the enhanced recovery after surgery program which involves 20 elements
| Study group | Role | What they receive |
|---|---|---|
| Control group | traditional perioperative care | |
| ERAS group | enhanced recovery after surgery perioperative care Receives: Other: enhanced recovery after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact on length of stay
total number of days spent in the hospital including any readmission
Measured: within 30 days of surgery
Secondary outcomes (1)
impact on overall morbidity
number of any perioperative adverse events
Measured: within 30 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Jul 2019
- Primary completion30 Apr 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PancreatectomyStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DESPOINA LIOTIRI, University of Thessaly
- Investigators
- DESPOINA LIOTIRI, MD, DESAIC, EDRA, MSc, PhD(c), Principal investigator, University of ThessalyATHINA SAMARA, MD, MSc, PhD(c), Principal investigator, University of ThessalyNIKOLAOS BEIS, MD, Principal investigator, University of ThessalyDIMITRIS ZACHAROULIS, PROFESSOR OF SURGERY, Study chair, University of ThessalyAlexandros Diamantis, MD, MSc, PhD, Principal investigator, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935448
- Sponsor's protocol ID
- UNIVERSITY OF THESSALY 2412
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Publications
Cardini B, Primavesi F, Maglione M, et al. Outcomes following pancreatic resections-results and challenges of an Austrian university hospital compared to nationwide data and international centres. Eur Surg (2019) 51:81-89. https://doi.org/10.1007/s10353-019-0585-x
Lau CS, Chamberlain RS. Enhanced Recovery After Surgery Programs Improve Patient Outcomes and Recovery: A Meta-analysis. World J Surg. 2017 Apr;41(4):899-913. doi: 10.1007/s00268-016-3807-4.
PubMed 27822725
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Enhanced Recovery After Surgery Program on Outcomes After Pancreatoduodenectomy; Experience From Two Referral Centers in Central Greece.
- ClinicalTrials.gov ID
- NCT06935448
- Acronym / sponsor ID
- UNIVERSITY OF THESSALY 2412
- Keywords
- pancreatectomy, enhanced recovery after surgery, pancreatic cancer resectable, outcomes research
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 20 Apr 2025 (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.
This study assesses whether patients with pancreatic cancer who undergo surgery experience improved outcomes following the implementation of a multidisciplinary care pathway, specifically an enhanced recovery after surgery (ERAS) program.
This pathway includes various interventions in the preoperative, intraoperative, and postoperative care of these patients, all aimed at enhancing their health status and postoperative results.
Detailed description
This prospective observational study is conducted by the same surgical team at two high-volume pancreatic cancer referral centers in Greece.
Patients undergoing elective pancreatic surgery are prospectively enrolled and managed according to a standardized ERAS protocol (ERAS group).
A control group, which received standard perioperative care before the implementation of ERAS, was retrospectively selected and matched based on demographic and clinical parameters.
The primary study endpoint is the length of hospital stay (LOS), while secondary endpoints include 30-day mortality and morbidity.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –traditional perioperative care |
| ERAS group | – | Other: enhanced recovery after surgeryenhanced recovery after surgery perioperative care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing pancreatic surgery in two pancreatic cancer referral centers in central Greece, namely the University Hospital of Larissa, and IASO Thessalias general hospital
Key inclusion criteria (3 listed)
- adult patients
- diagnosis of pancreatic cancer
- elective open pancreatic surgery
Key exclusion criteria (5 listed)
- age <18 years
- emergency pancreatic surgery
- other surgical procedures
- missing data
- lost to follow-up
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 |
|---|---|---|
| enhanced recovery after surgeryERAS group follows the enhanced recovery after surgery program which involves 20 elements | Other | ERAS group |
Primary outcome
impact on length of stay
Time frame: within 30 days of surgery
total number of days spent in the hospital including any readmission
1 secondary outcome
impact on overall morbidity
Time frame: within 30 days from surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- BackgroundCardini B, Primavesi F, Maglione M, et al. Outcomes following pancreatic resections-results and challenges of an Austrian university hospital compared to nationwide data and international centres. Eur Surg (2019) 51:81-89. https://doi.org/10.1007/s10353-019-0585-x
- Background: PubMed 27822725Lau CS, Chamberlain RS. Enhanced Recovery After Surgery Programs Improve Patient Outcomes and Recovery: A Meta-analysis. World J Surg. 2017 Apr;41(4):899-913. doi: 10.1007/s00268-016-3807-4.
- ERAS society guidelines for pancreatic surgeryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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.
ATHINA SAMARA, MD MSc PhD(c) contact
DESPOINA LIOTIRI, MD, DESAIC, EDRA, MSc, PhD(c) principal investigator
University of Thessaly
ATHINA SAMARA, MD, MSc, PhD(c) principal investigator
University of Thessaly
NIKOLAOS BEIS, MD principal investigator
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatectomy and Enhanced Recovery After Surgery, run by University of Thessaly at 1 site in Greece.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DESPOINA LIOTIRI, MD MSc PhD(c) (00302410996000, deppieliotiri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact on length of stay (time frame: within 30 days of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06935448, which also lists 2 linked publications.
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 20 Apr 2025.