Clinical trial NCT05025371: The Role of Systemic Immuno-inflammatory Factors in Resectable Pancreatic Adenocarcinoma
Official title: The Role of Systemic Immuno-inflammatory Factors in Resectable Pancreatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Cancer, Duct Cell Adenocarcinoma
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
Collaborators: name: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
First posted: 2021-08-27
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated in the Surgical Department of Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor Cluj-Napoca between January 2012 and December 2019

Brief summary: Pancreatic cancer is a highly aggressive malignancy, its prognosis remaining poor despite the current advances in treatment. Systemic inflammatory reaction has been recently recognized as an important factor in the progression of cancer. The immune-inflammatory response has been measured through different scores or ratios, that combine the values of circulating immune cells, like neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), systemic immune-inflammation index (SII), prognostic nutritional index (PNI). The utility of these scores in different types of cancer has been more and more discussed. In pancreatic cancer, there has been no definite conclusion regarding the role of systemic immune-inflammatory factors; since controversies still exist, a deeper exploration of this subject, through more studies is welcomed. Our study intends to analyze the utility of systemic immune-inflammatory markers in resectable pancreatic cancer.

Our study is an observational cohort study, with retrospective data collection; it is a single-center study, that takes place in a hospital with experience in hepato-bilio-pancreatic surgery. The investigators intended to evaluate the role of the circulating immune cells (neutrophils, lymphocytes, monocytes) and different immune-inflammatory scores (NLR, LMR, PLR, SII, PNI) in predicting the overall survival of patients diagnosed with pancreatic ductal adenocarcinoma, that undergo curative surgical treatment. The investigators intended to assess the prognosis power of these factors in both preoperative and postoperative settings, as well as their dynamic after surgery. Through this study, the investigators hope to identify easy-to determine and easy-to-use markers that can be incorporated in clinical practice and that can effectively predict survival in pancreatic cancer patients. Nonetheless, the investigators want to explore the dynamic of the immune-inflammatory markers after curative surgery.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of pancreatic ductal adenocarcinoma
* Curative surgical procedure

Exclusion Criteria:

* Other histopathological types of pancreatic malignancies
* Palliative surgical interventions
* Incomplete/ insufficient data

Primary outcomes:
measure: Overall survival
timeFrame: The last time of follow-up was April 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Regional Institute of Gastroenterology and Hepatology "Prof. Dr. O. Fodor"
state: Cluj
Study officials:
References:
citation: Schlanger D, Popa C, Pasca S, Seicean A, Al Hajjar N. The role of systemic immuno-inflammatory factors in resectable pancreatic adenocarcinoma: a cohort retrospective study. World J Surg Oncol. 2022 May 6;20(1):144. doi: 10.1186/s12957-022-02606-1.