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NCT Number: NCT06867172

Prevalence of Pancreatic Steatosis in Pancreatic Cystic Neoplasms and Pancreatic Adenocarcinoma

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof Dr Agrippa Ionescu; Clinical Emergency Hospital

Bucharest, Sector 1, 011356, Romania

Location status: Recruiting

Location contact

Mihai Ciocirlan, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

computerized tomography

Diagnostic 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.

Primary outcomes

  1. increased prevalence of pancreatic steatosis in neoplastic cystic lesions

    Time frame: From enrollment up to 5 years

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

Secondary outcomes

  1. Increased prevalence of pancreatic steatosis in PDAC

    Time frame: From enrollment up to 5 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Catalina Vladut, MD PhD

CONTACT

[email protected]

+40751015445 ext. 40

Sponsors and collaborators

Lead sponsor

Carol Davila University of Medicine and Pharmacy

Other

Registry information

Official study title

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

Acronym: SPACE

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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