Prevalence of Pancreatic Steatosis in Pancreatic Cystic Neoplasms and Pancreatic Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: computerized tomography, Endosonography (EUS).
- Who it may be relevant to
- Registry conditions: Pancreatic Steatosis, Pancreatic Cyst, Pancreatic Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Romania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Emerging Issue - Pancreatic Steatosis Prevalence in Pancreatic Cystic Neoplasms and Adenocarcinoma: Insights From a Single-center Retrospective Study
Overview
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
- 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.
Primary outcome measures
- increased prevalence of pancreatic steatosis in neoplastic cystic lesions [Time frame: From enrollment up to 5 years]
Secondary outcome measures (1)
- Increased prevalence of pancreatic steatosis in PDAC [Time frame: From enrollment up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Romania · 1 center
- Prof Dr Agrippa Ionescu; Clinical Emergency Hospital — Bucharest
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. PMID 25700304
- 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. PMID 30028443
Identifiers
NCT: NCT06867172 · 346833