Compliance With ERAS Protocol in Pancreatic Surgery, Stress Response and Outcomes

NCT05518643 | Recruiting

• 3 other identifiers: 2703147
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the impact of compliance with enhanced recovery after surgery (ERAS) program on patient reported outcomes (PROs), surgery-specific outcomes and stress response after pancreatic surgery. This prospective observational study will include all consecutive patients undergoing pancreatic surgery over a period of three years (2022 - 2025) at two sites, namely University General Hospital of Larissa and IASO Thessalias, in Greece. Patients will be prospectively enrolled after written informed consent. Data will be collected on patient characteristics, surgical and anaesthetic techniques, complications, and length of stay. Quality of life questionnaires will be administered to patients preoperatively, on the fith postoperative day, first follow-up after discharge, one month and six months after the operation. The stress response will be assessed by measuring the Neutrophil-Lymphocyte Ratio and Platelet-Lymphocyte Ratio (NLR and PLR) preoperatively, and on the first five postoperative days. Data will be collected on pancreatic surgery-specific complications such as delayed gastric emptying (DGE), post-pancreatectomy haemorrhage (PPH) and postoperative pancreatic fistula (POPF) formation. Anonymised data will be uploaded by the principal investigator on a protected excel spreadsheet for analysis.

Conditions

ERAS; Pancreas Cancer; Pancreas; Fistula; Delayed Gastric Emptying; Surgery-Complications; Pancreatic Hemorrhage; PROMs

Keywords

ERAS; Pancreas Cancer; PROMs; Stress response to surgery; Surgery-Complications; PLR; NLR; Quality of Life

Outcome Measures

Primary Outcomes (5)

• Change in patient-reported outcomes as measured by the Health Questionnaire EORTC QLQ-C30

  This questionnaire assesses health related quality of life (HRQoL) for cancer patients and includes 30 questions. The QLQ-C30 includes five functional scales (physical, role, emotional, cognitive, and social functioning); eight symptom scales or single items (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, and diarrhea); an item to assess financial difficulties; 1 global health status scale; and 1 global quality of life scale. Each one of the first 28 items has 4 levels: 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much. The last 2 questions ask the patient to rate their own health and quality of life on a scale from 1 (very poor) to 7 (excellent). PROMs questionnaires will be distributed in paper format and filled out by pen.

  1 week to 1 day before the operation, postoperative day 5, first follow-up 1 week post discharge, 1 month, and 6 months after the operation

• Change on the stress response to surgery measured by the Neutrophil-Lymphocyte and Platelet-Lymphocyte Ratio (NLR and PLR).

  NLR and PLR will be calculated by blood tests

  1 week to 1 day before the operation, and postoperative days 1-5

• Rate of Delayed Gastric Emptying (DGE)

  Number of DGE defined and graded according to the International Study Group of Pancreatic Surgery (ISGPS).

  within 6 weeks from operation

• Rate of Post Pancreatic Fistula (POPF) formation

  Number of POPF defined and graded according to the International Study Group of Pancreatic Fistula (ISGPF).

  within 6 weeks from operation

• Rate of Postoperative Pancreatic Haemorrhage (PPH)

  Number of PPH defined and graded according to the International Study Group of Pancreatic Surgery (ISGPS).

  within 6 weeks from operation

Secondary Outcomes (3)

• Length of hospital stay (LOS)

  within 6 weeks from operation

• Overall morbidity rate

  Within 3 months from operation

• Cancer recurrence rate

  within 1 year from operation

Interventions

ERAS protocol PROCEDURE

ERAS protocol as described above

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive community patients presented for pancreatic surgery

You may qualify if:

• all pancreatic surgery patients
• above the age of 18
• fluent greek speakers
• without communication barriers

You may not qualify if:

• younger than 18 years-old
• unable or unwilling to participate
• other surgical procedures
• communication barriers
• lost to follow-up

Sponsors & Collaborators

• University of Thessaly: lead
• IASO Thessalias: collaborator
• Larissa University Hospital: collaborator

Study Sites (1)

University of Thessaly

Larissa, 45100, Greece

RECRUITING

Related Publications (5)

• Melloul E, Lassen K, Roulin D, Grass F, Perinel J, Adham M, Wellge EB, Kunzler F, Besselink MG, Asbun H, Scott MJ, Dejong CHC, Vrochides D, Aloia T, Izbicki JR, Demartines N. Guidelines for Perioperative Care for Pancreatoduodenectomy: Enhanced Recovery After Surgery (ERAS) Recommendations 2019. World J Surg. 2020 Jul;44(7):2056-2084. doi: 10.1007/s00268-020-05462-w.

  PMID: 32161987 BACKGROUND

• Spolverato G, Maqsood H, Kim Y, Margonis G, Luo T, Ejaz A, Pawlik TM. Neutrophil-lymphocyte and platelet-lymphocyte ratio in patients after resection for hepato-pancreatico-biliary malignancies. J Surg Oncol. 2015 Jun;111(7):868-74. doi: 10.1002/jso.23900. Epub 2015 Apr 10.

  PMID: 25865111 BACKGROUND

• Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

  PMID: 8433390 BACKGROUND

• Bujang MA, Sa'at N, Sidik TMITAB, Joo LC. Sample Size Guidelines for Logistic Regression from Observational Studies with Large Population: Emphasis on the Accuracy Between Statistics and Parameters Based on Real Life Clinical Data. Malays J Med Sci. 2018 Jul;25(4):122-130. doi: 10.21315/mjms2018.25.4.12. Epub 2018 Aug 30.

  PMID: 30914854 BACKGROUND

• Austin PC, Steyerberg EW. Events per variable (EPV) and the relative performance of different strategies for estimating the out-of-sample validity of logistic regression models. Stat Methods Med Res. 2017 Apr;26(2):796-808. doi: 10.1177/0962280214558972. Epub 2014 Nov 19.

  PMID: 25411322 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Fistula; Gastroparesis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Stomach Diseases; Gastrointestinal Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Despoina Liotiri, Consultant

  University of Thessaly, IASO Thessalias

  PRINCIPAL INVESTIGATOR

• Dimitrios Zacharoulis, Professor

  University of Thessaly

  STUDY CHAIR

• Eleni Arnaoutoglou, Professor

  University of Thessaly

  STUDY DIRECTOR

Central Study Contacts

Despoina Liotiri, Consultant

CONTACT

00306947941422; deppieliotiri@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DESAIC, PgCert HBE(UK), EDRA, MSc, PhD(c), Consultant Anaesthesiologist

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: August 26, 2022
• Study Start: July 15, 2022
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

GR (1)