Prevalence of Pancreatic Steatosis in Pancreatic Cystic Neoplasms and Pancreatic Adenocarcinoma

NCT06867172 | Recruiting

• 1 other identifier: 346833
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Steatosis; Pancreatic Cyst; Pancreatic Adenocarcinoma

Keywords

pancreas; steatosis; cyst; cancer; adenocarcinoma; fat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Increased prevalence of pancreatic steatosis in PDAC

  From enrollment up to 5 years

Study Arms (3)

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

Interventions

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.

Pancreatic cyst

Endosonography (EUS) DIAGNOSTIC_TEST

EUS can better evaluate all pancreatic cysts, therefore is mandatory in this observational study.

Pancreatic cyst

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Group 1 - pancreatic cystic neoplastic lesion Group 2 - pancreatic ductal adenocarcinoma Group 3 - control

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead

Study Sites (1)

Prof Dr Agrippa Ionescu; Clinical Emergency Hospital

Bucharest, Sector 1, 011356, Romania

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pancreatic Cyst; Fatty Liver; Cysts; Neoplasms; Adenocarcinoma; Platelet Glycoprotein IV Deficiency

Interventions

Tomography, X-Ray Computed; Endosonography

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Liver Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Ultrasonography

Study Officials

• Mihai Ciocirlan, MD PhD

  Romanian Society of Digestive Endoscopy

  STUDY CHAIR

Central Study Contacts

Catalina Vladut, MD PhD

CONTACT

+40751015445; drcatalinavladut@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Gastroenterologist, Assistant Lecturer University of Medicine and Pharmacy

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: March 10, 2025
• Study Start: January 1, 2019
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)