Prevalence of Pancreatic Steatosis in Pancreatic Cystic Neoplasms and Pancreatic Adenocarcinoma

Carol Davila University of Medicine and Pharmacy66 enrolled

Overview

Several pancreatic neoplastic cystic lesions, such as IPMN (intrapapilary mucinous neoplasia), cystic neuroendocrine tumors (NET) and mucinous neoplasms, present a carcinogenetic risk, though it is yet unknown if this risk is increased in patients with pancreatic steatosis (PS). The primary objective of the study is to determine de prevalence of pancreatic steatosis in pancreatic neoplastic cysts and if pancreatic steatosis is increased in those lesions that pose a carcinogenetic risk. The secondary objective is to evaluate the prevalence of pancreatic steatosis in pancreatic adenocarcinoma.

Pancreatic steatosis has gained significant novel interest in the pathophysiology of PDAC and neoplastic cystic lesions. Pancreatic steatosis is the new emerging issue in pancreatology. Recently, pancreatic steatosis has gained significant novel interest in the pathophysiology of PDAC. The primary objective of the study is to determine de prevalence of pancreatic steatosis in pancreatic neoplastic cysts and if pancreatic steatosis is increased in those lesions that pose a carcinogenetic risk. Pancreatic ductal adenocarcinoma (PDAC) has a poor survival, predominantly as a result of its diagnosis in advanced stages. Pathological changes of steatosis are an independent determinant of PDAC, and these pathological changes are correlated with the attenuation of the pancreas on computed tomography (CT). The secondary objective is to evaluate the prevalence of pancreatic steatosis in pancreatic adenocarcinoma.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pancreatic Steatosis Pancreatic Cyst Pancreatic Adenocarcinoma

Interventions

computerized tomographyDIAGNOSTIC_TEST

Little is known about the prevalence of pancreatic steatosis in patients with pancreatic cystic lesions therefore this observational study aims to clarify the data.

Endosonography (EUS)DIAGNOSTIC_TEST

EUS can better evaluate all pancreatic cysts, therefore is mandatory in this observational study.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 or older * Patients with at least 1 pancreatic cystic lesion based on CT and EUS features, with a cyst size ≥ 5mm; or healthy subjects or PDAC (confirmed by histopathological exam). Exclusion Criteria: * No evidence of written informed consent * Patients with contraindications for endoscopy due to comorbidities * Metal stent in hepato-bilio-pancreatic region at time of baseline CT-imaging (vascular, luminal and biliary) * Acute pancreatitis at baseline imaging * Pancreatic surgery at baseline imaging in our department * Splenectomy * Patients with significant alcohol consumption, defined as alcohol intake of over 20 g daily (140 g weekly) for men and 10 g daily (70 g weekly) for women

Outcomes

Primary Outcomes

increased prevalence of pancreatic steatosis in neoplastic cystic lesions

Increased prevalence of pancreatic steatosis in neoplastic cystic lesions (mostly premalignant lesions)

Time frame: From enrollment up to 5 years

Secondary Outcomes

Increased prevalence of pancreatic steatosis in PDAC

The investigators are looking for increased prevalence of pancreatic steatosis in patients with PDAC and its association with stage of PDAC and PDAC-related mortality