An observational study in ERAS, Pancreas Cancer and Pancreas; Fistula, sponsored by University of Thessaly. Recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-22.
Sponsored by University of Thessaly · Observational
Among 27 studies in Pancreatic Neoplasms with a site in Greece — 5 open to participants now, 9 under way, 1 of them phase 3. Pancreatic Neoplasms · Greece.
Among the 27 studies in Pancreatic Neoplasms with a site in Greece, this one is one of 2 that started in 2022, is one of 9 observational ones, and was the 19th registered.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's planned enrollment of 120 is below the median of 200 across 740 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →5 of the 27 studies in Pancreatic Neoplasms with a site in Greece are open now, in 1 country. Each count lists the studies.
Of the 746 Pancreatic Neoplasms studies recruiting now, 479 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →27 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 2 started in 2022.
Median enrollment 450 across the 17 interventional studies, 120 across the 9 observational. Of the 15 that completed or were terminated, 5 (33%) have results posted.
11 of 27 have an industry lead sponsor. The 10 most frequent:
University of Thessaly is the lead sponsor of 195 studies on the registry; 44 are open to participants now.
University of Thessaly has 5 studies filed under Pancreatic Neoplasms — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 27 studies in Pancreatic Neoplasms with a site in Greece, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
In this study the ERAS program is applied to patients undergoing pancreatic surgery.This is a prospective observational cohort study.The study will take place in two hospitals, the University General Hospital of Larissa (academic center), and IASO Thessalias (largest private general hospital in Thessaly). The study period is three years between May 2022 and April 2025. All patients undergoing pancreatic surgery during this period will be invited to participate in the study. Recruitment will take place at the first appointment with the surgeon when the patient is listed for surgery. The patient will be provided with detailed information about the program which also includes an information leaflet. A written consent form will be signed by patients willing to participate in the study.
Enrolled patients will follow the ERAS pathway for pancreatic surgery during the preoperative, intraoperative, and postoperative period. The ERAS protocol is based on ERAS society recommendations for enhanced recovery after pancreatoduodenectomy.
The ERAS protocol consists of the following items:
First appointment preoperative:
Day before surgery:
Day of surgery:
Intraoperative
Postoperative:
The study group will use a checklist with ERAS criteria to follow for each patient and data will be collected on adherence rates to these criteria.
Data will be collected on patient demographics such as sex, age, Body Mass Index (BMI), American Society of Anaesthesiologists (ASA) physical status, and co-morbidities. Data will also be collected on surgical approach and technique, and tumour stage (pTNM). Data will be collected on complications including cardiovascular and respiratory complications, infectious complications (surgical site infection, chest infection, urinary tract infection, intra-abdominal abscess, sepsis), anaesthetic complications (severe pain, delirium, cognitive decline), functional complications (functional decline, new mobility aid use, pressure ulcer, discharge to nursing or rehabilitation facility), renal failure, ileus, return to theatre, readmission, and death. Data will be collected on length of stay and pancreatic surgery-specific complications such as DGE, PPH and POPF formation. International consensus guidelines will be used for definition and grading of these complications.
Quality of life will be assessed by Patient Reported Outcome Measures (PROMS). The stress response will be assessed by measuring NLR and PLR. After anonymization, all data will be prospectively uploaded by local investigators on a protected database and incorporated into a spreadsheet for data analysis.
The data will be analyzed using PROMs, NLR and PLR ratios, postoperative complications, length of hospital stay and cancer recurrence rates as the main outcome variables.The influence of the following factors will be assessed: age, BMI, sex, surgical technique, pTNM stage, preoperative comorbidity, ASA classification, previous SARS-CoV-2 infection, and compliance to the ERAS protocol (\<50%, 50-70%, 70-90%, >90%). Adherence will be calculated as the number of interventions fulfilled/20 (total number of preoperative and perioperative interventions).
The statistical model will be multivariate regression analysis. Sample size guidelines for observational studies with regression analysis are based on simulation studies and suggest that the minimum number of events per variable (EPV) should be 10. According to these guidelines the minimum sample size is calculated at 90. To account for 25% loss to follow-up the investigators aim for a total enrollment goal of 120 participants. IBM® SPSS 26 software will be used for statistical analysis. Continuous variables will be compared with One-Way ANOVA or Student's t test for parametric data and with a non-parametric test (Mann-Whitney U test or Kruskal-Wallis test), as indicated. Categorical data will be analysed by using the chi squared or Fisher's exact test where indicated. Quantitative values will be expressed as mean ± standard deviation (SD), median and range, categorical data with percentage frequencies. The odds ratio (OR) will be presented followed by 95% confidence interval (95% CI). Differences in survival and complications between different degrees of compliance will be assessed by the application of log rank test. P \< 0.05 will be considered statistically significant.
All consecutive community patients presented for pancreatic surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
ERAS protocol as described above
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.
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: within 6 weeks from operation
Length of hospital stay (LOS)
Total number of days spent in the hospital (including any readmission)
Time frame: within 6 weeks from operation
Overall morbidity rate
Number of any perioperative adverse events graded according to Clavien-Dindo
Time frame: Within 3 months from operation
Cancer recurrence rate
Number of patients with cancer recurrence with metastases
Time frame: within 1 year from operation
Plan to share: Undecided — 6 months after the end of the study
Started Jul 2022 (actual). Primary completion is estimated for May 2025, 34 months after the start.
Of 318 non-industry observational studies under Pancreatic Neoplasms, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 182. This study's planned 34 months is below that.
Counting every sponsor, half of 352 studies reached it within 60 months; a quarter within 34 and three quarters within 182.
How these figures are worked out, and which studies are left out of them.
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