Aspiration of Duodenopancreatic Juice After Secretin Stimulation vs Endoscopic Aspiration for Molecular Analysis of Intraductal Papillary Mucinous Intraductal Neoplasia.

Proportion of patients with IPMN with GNAS and KRAS mutations in intracystic fluid obtained by EUS-FNA versus pancreatic juice obtained by ADPJ-secr after both techniques.

Time frame · Through study completion, an average of 30 months

In intracystic fluid obtained by EUS-FNA versus pancreatic juice obtained by ADPJ-secr after both techniques.

Proportion of patients with IPMN with Tp53 mutations.

Time frame · Through study completion, an average of 30 months

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

Time frame · Through study completion, an average of 30 months

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.

Time frame · Through study completion, an average of 30 months

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

Time frame · Through study completion, an average of 30 months

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

Time frame · Through study completion, an average of 30 months

In samples obtained by EUS-FNA versus ADPJ-secr within 12 months of study entry.

Proportion of patients undergoing pancreatic resection with Tp53 mutations

Time frame · Through study completion, an average of 30 months

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.

Time frame · Through study completion, an average of 30 months

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.

Time frame · Through study completion, an average of 30 months

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.

Time frame · Through study completion, an average of 30 months

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.

Time frame · Through study completion, an average of 30 months

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 \[wild type\]).