Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Neoplasms, Cystic, Mucinous, and Serous

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Secretin

Hormones

Hormone Antagonists

Duodenopancreatic aspiration after secretin stimulation will be performed followed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA)

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) will be performed followed by duodenopancreatic aspiration after secretin stimulation

Secretin will be administered intravenous during 1 minute at a dose of 0,2 μg/Kg previous to the endoscopic procedure.

Endoscopic aspiration of duodenopancreatic juice after secretin stimulation

Endoscopic aspiration

Endoscopic ultrasound-guided fine needle aspiration of intraductal papillary mucinous intraductal neoplasia (IPMN).

Endoscopic ultrasound-guided fine needle aspiration

Àngels Ginès

Àngels Ginès, MD

Study to evaluate aspiration of duodenopancreatic juice after secretin stimulation (ADPJ-secr)versus endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for molecular analysis of intraductal papillary mucinous intraductal neoplasia.

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

Aspiration of Duodenopancreatic Juice After Secretin Stimulation (ADPJ-secr-) vs Endoscopic Aspiration (EUS-FNA) for Molecular Analysis of Intraductal Papillary Mucinous Intraductal Neoplasia (IPMN).

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

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.

In samples obtained by EUS-FNA versus ADPJ-secr after performing both techniques.

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.

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

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.

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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.

Spots Global Cancer Trial Database for intraductal papillary mucinous neoplasm of pancreas