NCT06935448

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

5.8 years

First QC Date

April 8, 2025

Last Update Submit

April 16, 2025

Conditions

Keywords

pancreatectomyenhanced recovery after surgerypancreatic cancer resectableoutcomes research

Outcome Measures

Primary Outcomes (1)

  • impact on length of stay

    total number of days spent in the hospital including any readmission

    within 30 days of surgery

Secondary Outcomes (1)

  • impact on overall morbidity

    within 30 days from surgery

Study Arms (2)

Control group

traditional perioperative care

ERAS group

enhanced recovery after surgery perioperative care

Other: enhanced recovery after surgery

Interventions

ERAS group follows the enhanced recovery after surgery program which involves 20 elements

ERAS group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Thessaly

Larissa, Greece

RECRUITING

Related Publications (2)

  • 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

    BACKGROUND
  • 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.

    PMID: 27822725BACKGROUND

Related Links

MeSH Terms

Interventions

Enhanced Recovery After Surgery

Intervention Hierarchy (Ancestors)

Perioperative CareSurgical Procedures, Operative

Study Officials

  • DESPOINA LIOTIRI, MD, DESAIC, EDRA, MSc, PhD(c)

    University of Thessaly

    PRINCIPAL INVESTIGATOR
  • ATHINA SAMARA, MD, MSc, PhD(c)

    University of Thessaly

    PRINCIPAL INVESTIGATOR
  • NIKOLAOS BEIS, MD

    University of Thessaly

    PRINCIPAL INVESTIGATOR
  • DIMITRIS ZACHAROULIS, PROFESSOR OF SURGERY

    University of Thessaly

    STUDY CHAIR
  • Alexandros Diamantis, MD, MSc, PhD

    University of Thessaly

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DESPOINA LIOTIRI, MD MSc PhD(c)

CONTACT

ATHINA SAMARA, MD MSc PhD(c)

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 8, 2025

First Posted

April 20, 2025

Study Start

July 1, 2019

Primary Completion

April 30, 2025

Study Completion

May 30, 2025

Last Updated

April 20, 2025

Record last verified: 2025-04

Locations