An observational study in Pancreatic Steatosis, Pancreatic Cyst and Pancreatic Adenocarcinoma, sponsored by Carol Davila University of Medicine and Pharmacy. Recruiting at 1 site in Romania. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by Carol Davila University of Medicine and Pharmacy · Observational
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.
97 studies on the registry are indexed under Pancreatic Cyst; 37 are open to participants now.
This study's planned enrollment of 66 is below the median of 300 across 55 observational studies indexed under Pancreatic Cyst.
Browse Pancreatic Cyst studies →Carol Davila University of Medicine and Pharmacy is the lead sponsor of 25 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Group 1 - pancreatic cystic neoplastic lesion Group 2 - pancreatic ductal adenocarcinoma Group 3 - control
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoplastic pancreatic cystic lesion
Diagnostic Test: computerized tomography · Diagnostic Test: Endosonography (EUS)
Pancreatic ductal adenocarcinoma for supplementary analysis
Control group for comparison
Little is known about the prevalence of pancreatic steatosis in patients with pancreatic cystic lesions therefore this observational study aims to clarify the data.
EUS can better evaluate all pancreatic cysts, therefore is mandatory in this observational study.
increased prevalence of pancreatic steatosis in neoplastic cystic lesions
Increased prevalence of pancreatic steatosis in neoplastic cystic lesions (mostly premalignant lesions)
Time frame: From enrollment up to 5 years
Increased prevalence of pancreatic steatosis in PDAC
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
Time frame: From enrollment up to 5 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The study is single center therefore no IPD will be needed
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Carol Davila University of Medicine and Pharmacy