Prevalence of Pancreatic Steatosis in Pancreatic Cystic Neoplasms and Pancreatic Adenocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCarol Davila University of Medicine and Pharmacy
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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
Trial population
Group 1 - pancreatic cystic neoplastic lesion Group 2 - pancreatic ductal adenocarcinoma Group 3 - control
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
computerized tomography
Diagnostic testLittle 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 testEUS can better evaluate all pancreatic cysts, therefore is mandatory in this observational study.
Treatment groups
66 Participants
are divided into 3 treatment groupsGroup A: Pancreatic cyst2 interventions
Group B: PDAC0 interventions
Group C: Control group0 interventions
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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
Time frame
From enrollment up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov