Prevalence of Pancreatic Steatosis in Pancreatic Cystic Neoplasms and Pancreatic Adenocarcinoma (SPACE)

Carol Davila University of Medicine and Pharmacy

Status: Enrolling

Conditions: Pancreatic Adenocarcinoma; Pancreatic Cyst; Pancreatic Steatosis

Treatments: Diagnostic Test: computerized tomography; Diagnostic Test: Endosonography (EUS)

Study type: Observational

Funder types: Other

Identifiers

NCT06867172

346833

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

66 participants in 3 patient groups

Pancreatic cyst

Description:

Neoplastic pancreatic cystic lesion

Treatment:

Diagnostic Test: Endosonography (EUS)

Diagnostic Test: computerized tomography

PDAC

Description:

Pancreatic ductal adenocarcinoma for supplementary analysis

Control group

Description:

Control group for comparison