Proportion of patients with IPMN with Tp53 mutations.
In samples obtained by EUS-FNA versus ADPJ-secr after performing both techniques, in the subgroup of patients undergoing pancreatic resection within 12 months after study entry.
DNA concentration expressed in ng/µl
In samples obtained by EUS-FNA versus ADPJ-secr after performing both techniques.
Proportion of suitable samples obtained by the two techniques under study (ADPJ-secr and EUS-FNA) for molecular analysis.
A sample is defined as suitable when it is read by the Qubit fluorometer, which only detects full double-stranded DNA suitable for molecular analysis.
Proportion of patients undergoing pancreatic resection with a pathological diagnosis of IPMN who have mutations in GNAS and/or KRAS
In samples obtained by EUS-FNA versus ADPJ-secr within 12 months of study entry.
Proportion of patients undergoing pancreatic resection without a pathological diagnosis of IPMN who do not have GNAS and/or KRAS mutations
In samples obtained by EUS-FNA versus ADPJ-secr within 12 months of study entry.
Proportion of patients undergoing pancreatic resection with Tp53 mutations
In samples obtained by both techniques under study (ADPJ-secr vs EUS-FNA) who have advanced neoplasia in the surgical resection specimen after surgery performed within 12 months after study inclusion.
Advanced neoplasia is defined as the presence of IPMN with high-grade dysplasia or IMPN with associated invasive carcinoma according to Lokuhetty D, et al. Digestive SystemTumours: WHO Classification of Tumours, International Agency for Research on Cancer, 2019.
Proportion of patients undergoing pancreatic resection without Tp53 mutations.
In samples obtained by both techniques under study (ADPJ-secr vs EUS-FNA) who do not have advanced neoplasia in the surgical resection specimen after surgery performed within 12 months after inclusion in the study.
Advanced neoplasia is defined as the presence of IPMN with high-grade dysplasia or IPMN with associated invasive carcinoma according to Lokuhetty D, et al. Digestive System Tumours: WHO Classification of Tumours, International Agency for Research on Cancer, 2019.
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (diameter of the largest cystic lesion) obtained by EUS.
To compare if diameter of the largest cystic lesion in mm is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (maximum diameter of the main pancreatic duct) obtained by EUS.
To compare if median maximum diameter of the main pancreatic duct assessed by EUS and measured in mm is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (type of main pancreatic duct dilatation) obtained by EUS.
To compare if the proportion of patients that present a segmental main pancreatic duct dilatation assessed by EUS is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (location of the lesion) obtained by EUS.
To compare if the proportion of cystic lesions located in the pancreatic head, pancreatic body or pancreatic tail assessed by EUS are different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (presence > 1 cystic lesion) obtained by EUS.
To compare if the proportion of patients with > 1 pancreatic cystic lesion assessed by EUS is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (mural nodules) obtained by EUS.
To compare if the proportion of patients that present mural nodules assessed by EUS is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (signs of chronic pancreatitis) obtained by EUS.
To compare if the proportion of patients that present features of chronic pancreatitis assessed by EUS is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (intraductal calcifications) obtained by EUS.
To compare if the proportion of patients that present intraductal calcifications assessed by EUS is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (pancreatic atrophy) obtained by EUS.
To compare if the proportion of patients that present pancreatic atrophy assessed by EUS is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to age
To compare if median of age measured in years is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to sex
To compare if the proportion of male or female patients are different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to smoking
To compare if the proportion of patients with reported active smoking is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to chronic alcohol consumption
To compare if the proportion of patients with high risk chronic alcohol consumption (> 21 standard drinks for men, > 14 standard drinks for women) is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to hypertension
To compare if the proportion of patients with hypertension is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to type 2 diabetes mellitus
To compare if the proportion of patients with type 2 diabetes mellitus is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to heart failure
To compare if the proportion of patients with chronic heart failure is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to chronic liver disease.
To compare if the proportion of patients with chronic liver disease is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to chronic kidney disease.
To compare if the proportion of patients with chronic kidney disease is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to neoplasms.
To compare if the proportion of patients with previous neoplasm in past medical history is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to history of acute pancreatitis
To compare if the proportion of patients with history of acute pancreatitis in past medical history is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to previous diagnosis of chronic pancreatitis
To compare if the proportion of patients with history of chronic pancreatitis in past medical history is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to family history (1st degree) of pancreatic cancer
To compare if the proportion of patients with history of pancreatic cancer in first degree relatives is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to time since diagnosis of IPMN
To compare if time since diagnosis of IPMN measured in years is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to morphological type of IPMN
To compare if the proportions of patients with MD-IPMN, BD-IPMN or mixed-type IPMN are different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of amylase
To compare if mean blood levels of amylase measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of lipase
To compare if mean blood levels of lipase measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of creatinine
To compare if mean blood levels of creatinine measured in mg/dl is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of total bilirrubin
To compare if mean blood levels of total bilurrubin measured in mg/dl is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of AST
To compare if mean blood levels of AST measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of ALT (U/L)
To compare if mean blood levels of ALT measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of GGT (U/L)
To compare if mean blood levels of GGT measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of alkaline phosphatase (U/L)
To compare if mean blood levels of alkaline phosphatase measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of hemoglobin (g/L)
To compare if mean blood levels of hemoglobin measured in g/l is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of platelets (U/L)
To compare if mean blood total count of platelets measured in units per microliter is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of CA 19.9 (u/L)
To compare if mean blood levels of CA 19.9 measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of CEA (U/l)
To compare if mean blood levels of CEA measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of glycated hemoglobin.(%).
To compare if mean blood levels of glycated hemoglobin measured in % is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
To assess whether mutational status predicts the occurrence of adverse effects associated with the techniques under study at 24 hours and 7 days following the performance of the techniques under study.
To compare if the proportion of patients with adverse effects associated with the techniques under study at 24 hours and 7 days is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]). Adverse effects will be reported following the American Society of Gastrointestinal Endoscopy (ASGE) (P.B. Cotton, et al. Gastrointest Endosc, 2010) and the WHO Toxicity Grading Scale for Determining the Severity of Adverse Events, 2003.
Proportion of patients with Serious Adverse Events