2019-01-01
2025-03-31
2025-06-30
66
NCT06867172
Carol Davila University of Medicine and Pharmacy
Carol Davila University of Medicine and Pharmacy
OBSERVATIONAL
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.
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 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
: Pancreatic cyst Neoplastic pancreatic cystic lesion | DIAGNOSTIC_TEST: computerized tomography
DIAGNOSTIC_TEST: Endosonography (EUS)
|
: PDAC Pancreatic ductal adenocarcinoma for supplementary analysis | |
: Control group Control group for comparison |
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
increased prevalence of pancreatic steatosis in neoplastic cystic lesions | Increased prevalence of pancreatic steatosis in neoplastic cystic lesions (mostly premalignant lesions) | From enrollment up to 5 years |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
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 | From enrollment up to 5 years |
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 |
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
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.