Clinical trial NCT06935448: Effect of an Enhanced Recovery After Surgery Program on Outcomes After Pancreatoduodenectomy
Official title: Effect of an Enhanced Recovery After Surgery Program on Outcomes After Pancreatoduodenectomy; Experience From Two Referral Centers in Central Greece.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatectomy
Enhanced Recovery After Surgery
Pancreatic Cancer Resectable
Keywords: pancreatectomy
enhanced recovery after surgery
pancreatic cancer resectable
outcomes research
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* adult patients
* diagnosis of pancreatic cancer
* elective open pancreatic surgery

Exclusion Criteria:

* age \<18 years
* emergency pancreatic surgery
* other surgical procedures
* missing data
* lost to follow-up

Primary outcomes:
measure: impact on length of stay
timeFrame: within 30 days of surgery
Secondary outcomes:
measure: impact on overall morbidity
timeFrame: within 30 days from surgery
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University of Thessaly
Study officials:
affiliation: University of Thessaly
name: DESPOINA LIOTIRI, MD, DESAIC, EDRA, MSc, PhD(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Thessaly
name: ATHINA SAMARA, MD, MSc, PhD(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Thessaly
name: NIKOLAOS BEIS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Thessaly
name: DIMITRIS ZACHAROULIS, PROFESSOR OF SURGERY
role: STUDY_CHAIR
affiliation: University of Thessaly
name: Alexandros Diamantis, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.