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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatic cyst | Neoplastic pancreatic cystic lesion |
| |
| PDAC | Pancreatic ductal adenocarcinoma for supplementary analysis | ||
| Control group | Control group for comparison |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computerized tomography | Diagnostic Test | Little is known about the prevalence of pancreatic steatosis in patients with pancreatic cystic lesions therefore this observational study aims to clarify the data. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Group 1 - pancreatic cystic neoplastic lesion Group 2 - pancreatic ductal adenocarcinoma Group 3 - control
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catalina Vladut, MD PhD | Contact | +40751015445 | 40 | drcatalinavladut@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mihai Ciocirlan, MD PhD | Romanian Society of Digestive Endoscopy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof Dr Agrippa Ionescu; Clinical Emergency Hospital | Recruiting | Bucharest | Sector 1 | 011356 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25700304 | Background | 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. | |
| 30028443 | Background |
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The study is single center therefore no IPD will be needed
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 20, 2025 | Feb 22, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010181 | Pancreatic Cyst |
| D005234 | Fatty Liver |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| C564245 | Platelet Glycoprotein IV Deficiency |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| D019160 | Endosonography |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Endosonography (EUS) | Diagnostic Test | EUS can better evaluate all pancreatic cysts, therefore is mandatory in this observational study. |
|
| 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |
| D014463 | Ultrasonography |