Clinical trial NCT06867172: Prevalence of Pancreatic Steatosis in Pancreatic Cystic Neoplasms and Pancreatic Adenocarcinoma
Official title: The Emerging Issue - Pancreatic Steatosis Prevalence in Pancreatic Cystic Neoplasms and Adenocarcinoma: Insights From a Single-center Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Steatosis
Pancreatic Cyst
Pancreatic Adenocarcinoma
Keywords: pancreas
steatosis
cyst
cancer
adenocarcinoma
fat
Lead sponsor: Carol Davila University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Group 1 - pancreatic cystic neoplastic lesion Group 2 - pancreatic ductal adenocarcinoma Group 3 - control

Brief summary: 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.

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

Primary outcomes:
measure: increased prevalence of pancreatic steatosis in neoplastic cystic lesions
timeFrame: From enrollment up to 5 years
Secondary outcomes:
measure: Increased prevalence of pancreatic steatosis in PDAC
timeFrame: From enrollment up to 5 years
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Prof Dr Agrippa Ionescu; Clinical Emergency Hospital
state: Sector 1
Study officials:
affiliation: Romanian Society of Digestive Endoscopy
name: Mihai Ciocirlan, MD PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.