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Prevalence of Pancreatic Steatosis in Pancreatic Cystic Neoplasms and Pancreatic Adenocarcinoma


2019-01-01


2025-03-31


2025-06-30


66

Study Overview

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.

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.

  • Pancreatic Steatosis
  • Pancreatic Cyst
  • Pancreatic Adenocarcinoma
  • DIAGNOSTIC_TEST: computerized tomography
  • DIAGNOSTIC_TEST: Endosonography (EUS)
  • 346833

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2024-09-27  

N/A  

2025-03-06  

2025-03-06  

N/A  

2025-03-10  

2025-03-10  

N/A  

2025-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
: Pancreatic cyst

Neoplastic pancreatic cystic lesion

DIAGNOSTIC_TEST: computerized tomography

  • 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_TEST: Endosonography (EUS)

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

Pancreatic ductal adenocarcinoma for supplementary analysis

: Control group

Control group for comparison

Primary Outcome MeasuresMeasure DescriptionTime Frame
increased prevalence of pancreatic steatosis in neoplastic cystic lesionsIncreased prevalence of pancreatic steatosis in neoplastic cystic lesions (mostly premalignant lesions)From enrollment up to 5 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Increased prevalence of pancreatic steatosis in PDACThe investigators are looking for increased prevalence of pancreatic steatosis in patients with PDAC and its association with stage of PDAC and PDAC-related mortalityFrom enrollment up to 5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Catalina Vladut, MD PhD

Phone Number: +40751015445

Email: drcatalinavladut@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • STUDY_CHAIR: Mihai Ciocirlan, MD PhD, Romanian Society of Digestive Endoscopy

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    • Rebours V, Gaujoux S, d'Assignies G, Sauvanet A, Ruszniewski P, Levy P, Paradis V, Bedossa P, Couvelard A. Obesity and Fatty Pancreatic Infiltration Are Risk Factors for Pancreatic Precancerous Lesions (PanIN). Clin Cancer Res. 2015 Aug 1;21(15):3522-8. doi: 10.1158/1078-0432.CCR-14-2385. Epub 2015 Feb 19.
    • Kashiwagi K, Seino T, Fukuhara S, Minami K, Horibe M, Iwasaki E, Takaishi H, Itoh K, Sugino Y, Inoue N, Iwao Y, Kanai T. Pancreatic Fat Content Detected by Computed Tomography and Its Significant Relationship With Intraductal Papillary Mucinous Neoplasm. Pancreas. 2018 Oct;47(9):1087-1092. doi: 10.1097/MPA.0000000000001103.