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Prevalence of Pancreatic Steatosis in Pancreatic Cystic Neoplasms and Pancreatic Adenocarcinoma

The Emerging Issue - Pancreatic Steatosis Prevalence in Pancreatic Cystic Neoplasms and Adenocarcinoma: Insights From a Single-center Retrospective Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06867172
Acronym
SPACE
Enrollment
66
Registered
2025-03-10
Start date
2019-01-01
Completion date
2025-06-30
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Steatosis, Pancreatic Cyst, Pancreatic Adenocarcinoma

Keywords

pancreas, steatosis, cyst, cancer, adenocarcinoma, fat

Brief summary

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.

Detailed 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.

Interventions

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

DIAGNOSTIC_TESTEndosonography (EUS)

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

Sponsors

Carol Davila University of Medicine and Pharmacy
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
increased prevalence of pancreatic steatosis in neoplastic cystic lesionsFrom enrollment up to 5 yearsIncreased prevalence of pancreatic steatosis in neoplastic cystic lesions (mostly premalignant lesions)

Secondary

MeasureTime frameDescription
Increased prevalence of pancreatic steatosis in PDACFrom enrollment up to 5 yearsThe investigators are looking for increased prevalence of pancreatic steatosis in patients with PDAC and its association with stage of PDAC and PDAC-related mortality

Countries

Romania

Contacts

Primary ContactCatalina Vladut, MD PhD
drcatalinavladut@gmail.com+40751015445

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026