Prevalence of Pancreatic Steatosis in Pancreatic Cystic Neoplasms and Pancreatic Adenocarcinoma
NCT ID: NCT06867172
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
66 participants
OBSERVATIONAL
2019-01-01
2025-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Pancreatic cyst
Neoplastic pancreatic cystic lesion
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.
Endosonography (EUS)
EUS can better evaluate all pancreatic cysts, therefore is mandatory in this observational study.
PDAC
Pancreatic ductal adenocarcinoma for supplementary analysis
No interventions assigned to this group
Control group
Control group for comparison
No interventions assigned to this group
Interventions
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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.
Endosonography (EUS)
EUS can better evaluate all pancreatic cysts, therefore is mandatory in this observational study.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Carol Davila University of Medicine and Pharmacy
OTHER
Responsible Party
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Vladut Catalina
Principal Investigator, Gastroenterologist, Assistant Lecturer University of Medicine and Pharmacy
Principal Investigators
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Mihai Ciocirlan, MD PhD
Role: STUDY_CHAIR
Romanian Society of Digestive Endoscopy
Locations
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Prof Dr Agrippa Ionescu; Clinical Emergency Hospital
Bucharest, Sector 1, Romania
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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346833
Identifier Type: -
Identifier Source: org_study_id
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