Pancreatic SteatosisSPACENCT06867172
Prevalence of Pancreatic Steatosis in Pancreatic Cystic Neoplasms and Pancreatic Adenocarcinoma
An observational study of Pancreatic Steatosis and Pancreatic Cyst, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Steatosis, Pancreatic Cyst, Pancreatic Adenocarcinoma
- What is being tested?
- computerized tomography and Endosonography (EUS)
- How many people
- 66 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2019to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1 - pancreatic cystic neoplastic lesion Group 2 - pancreatic ductal adenocarcinoma Group 3 - control
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Prof Dr Agrippa Ionescu; Clinical Emergency Hospital
Bucharest, Sector 1, 011356
Mihai Ciocirlan, MD, ciocirlan@hey.com
About this study
Official title: The Emerging Issue - Pancreatic Steatosis Prevalence in Pancreatic Cystic Neoplasms and Adenocarcinoma: Insights From a Single-center Retrospective Study
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.
Read the 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.
- Being tested
- computerized tomography, Endosonography (EUS)
- Keywords
- pancreas, steatosis, cyst, cancer, adenocarcinoma, fat
- Medical subject headings
- Pancreatic Cyst, Fatty Liver, Cysts, Neoplasms, Adenocarcinoma, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized tomographyDiagnostic 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.
Endosonography (EUS)Diagnostic test
EUS can better evaluate all pancreatic cysts, therefore is mandatory in this observational study.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic cyst | Neoplastic pancreatic cystic lesion Receives: Diagnostic Test: computerized tomography; Diagnostic Test: Endosonography (EUS) | |
| PDAC | Pancreatic ductal adenocarcinoma for supplementary analysis | |
| Control group | Control group for comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
increased prevalence of pancreatic steatosis in neoplastic cystic lesions
Increased prevalence of pancreatic steatosis in neoplastic cystic lesions (mostly premalignant lesions)
Measured: From enrollment up to 5 years
Secondary outcomes (1)
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
Measured: From enrollment up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Jan 2019
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic SteatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carol Davila University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladut Catalina, Carol Davila University of Medicine and Pharmacy
- Investigators
- Mihai Ciocirlan, MD PhD, Study chair, Romanian Society of Digestive Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867172
- Sponsor's protocol ID
- 346833
- Acronym
- SPACE
- Status last verified
- Mar 2025
- First submitted
- 27 Sep 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is single center therefore no IPD will be needed
Publications
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.
PubMed 25700304Kashiwagi 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.
PubMed 30028443Vladut C, Bilous D, Sandru V, Buza B, Prodan R, Bugeac C, Chiriac O, Tianu E, Ciocirlan M. Emerging Issue - Fatty Pancreas in Pancreatic Cystic Neoplasms: Results of a Matched Case-Control Study. Dig Dis Sci. 2026 Aug 21. doi: 10.1007/s10620-026-10174-7. Online ahead of print.
PubMed 42627603
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Emerging Issue - Pancreatic Steatosis Prevalence in Pancreatic Cystic Neoplasms and Adenocarcinoma: Insights From a Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT06867172
- Acronym / sponsor ID
- SPACE / 346833
- Keywords
- pancreas, steatosis, cyst, cancer, adenocarcinoma, fat
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Carol Davila University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pancreatic cyst | – | Diagnostic Test: computerized tomography, Diagnostic Test: Endosonography (EUS)Neoplastic pancreatic cystic lesion |
| PDAC | – | –Pancreatic ductal adenocarcinoma for supplementary analysis |
| Control group | – | –Control group for comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1 - pancreatic cystic neoplastic lesion Group 2 - pancreatic ductal adenocarcinoma Group 3 - control
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computerized tomographyLittle is known about the prevalence of pancreatic steatosis in patients with pancreatic cystic lesions therefore this observational study aims to clarify the data. | Diagnostic test | Pancreatic cyst |
| Endosonography (EUS)EUS can better evaluate all pancreatic cysts, therefore is mandatory in this observational study. | Diagnostic test | Pancreatic cyst |
Primary outcome
increased prevalence of pancreatic steatosis in neoplastic cystic lesions
Time frame: From enrollment up to 5 years
Increased prevalence of pancreatic steatosis in neoplastic cystic lesions (mostly premalignant lesions)
1 secondary outcome
Increased prevalence of pancreatic steatosis in PDAC
Time frame: From enrollment up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Background: PubMed 25700304Rebours 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.
- Background: PubMed 30028443Kashiwagi 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.
- Derived from this study: PubMed 42627603Vladut C, Bilous D, Sandru V, Buza B, Prodan R, Bugeac C, Chiriac O, Tianu E, Ciocirlan M. Emerging Issue - Fatty Pancreas in Pancreatic Cystic Neoplasms: Results of a Matched Case-Control Study. Dig Dis Sci. 2026 Aug 21. doi: 10.1007/s10620-026-10174-7. Online ahead of print.
- Individual participant dataSharing planned: No. The study is single center therefore no IPD will be needed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mihai Ciocirlan, MD PhD study chair
Romanian Society of Digestive Endoscopy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Steatosis and Pancreatic Cyst, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catalina Vladut, MD PhD (+40751015445 ext. 40, drcatalinavladut@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increased prevalence of pancreatic steatosis in neoplastic cystic lesions (time frame: From enrollment up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06867172, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.