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2019-07-01
2025-04-30
2025-05-30
170
NCT06935448
University of Thessaly
University of Thessaly
OBSERVATIONAL
Effect of an Enhanced Recovery After Surgery Program on Outcomes After Pancreatoduodenectomy
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-04-08 | N/A | 2025-04-16 |
2025-04-16 | N/A | 2025-04-20 |
2025-04-20 | N/A | 2025-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Control group traditional perioperative care | |
| : ERAS group enhanced recovery after surgery perioperative care | OTHER: enhanced recovery after surgery
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| impact on length of stay | total number of days spent in the hospital including any readmission | within 30 days of surgery |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| impact on overall morbidity | number of any perioperative adverse events | within 30 days from surgery |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: DESPOINA LIOTIRI, MD MSc PhD(c) Phone Number: 00302410996000 Email: deppieliotiri@gmail.com |
Study Contact Backup Name: ATHINA SAMARA, MD MSc PhD(c) Phone Number: Email: at.samara93@gmail.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
