UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061420 |
|---|---|
| Receipt number | R000070280 |
| Scientific Title | National Retrospective Survey on the Prevalence of Fatty Pancreas in Patients with Pancreatic Cancer |
| Date of disclosure of the study information | 2026/05/27 |
| Last modified on | 2026/04/30 21:34:51 |
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Basic information
Public title
National Retrospective Survey on the Prevalence of Fatty Pancreas in Patients with Pancreatic Cancer
Acronym
Fatty Pancreas in Pancreatic Cancer: A Nationwide Retrospective Study
Scientific Title
National Retrospective Survey on the Prevalence of Fatty Pancreas in Patients with Pancreatic Cancer
Scientific Title:Acronym
Fatty Pancreas in Pancreatic Cancer: A Nationwide Retrospective Study
Region
| Japan |
Condition
Condition
Pancreatic cancer, Pancreatic neuroendocrine tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Fatty pancreas (diffuse pancreatic steatosis) may induce intra-pancreatic inflammation and predispose to pancreatic cancer. The primary aim is to determine the prevalence (proportion) of fatty pancreas among patients with pancreatic cancer. Secondary aims include comparing clinical backgrounds, prognosis, and postoperative pancreatic fistula between fatty pancreas and non-fatty pancreas groups, and exploring risk factors for pancreatic fat accumulation, prognostic factors for pancreatic cancer, and pathological features of fatty pancreas.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence (proportion) of fatty pancreas
Definition: Pancreatic CT attenuation < 30 HU on non-contrast CT (suggesting>10% fat accumulation)
Assessment timing: Preoperative CT images (surgical cases between January 2015 and December 2020) assessed by central review
Key secondary outcomes
1. Comparison of clinical backgrounds between fatty pancreas and non-fatty pancreas groups (age, sex, BMI, diabetes, smoking, alcohol, etc.)
2. Comparison of prognosis (overall survival) between the two groups
3. Comparison of postoperative pancreatic fistula (POPF) between the two groups
4. Exploration of prognostic factors for pancreatic cancer (Cox regression)
5. Exploration of risk factors for pancreatic fat accumulation (multiple regression, logistic regression, modified Poisson regression)
6. Pathological assessment of fatty pancreas (distribution pattern of pancreatic fat, presence of lipid droplets in acinar cells, etc.)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All of the following criteria must be met:
1. Patients who underwent distal pancreatectomy for cancer of the pancreatic tail or neuroendocrine tumor of the pancreatic tail between January 2015 and December 2020, with pathologically confirmed pancreatic malignancy or pancreatic neuroendocrine tumor
2. Patients who underwent preoperative abdominal CT (both non-contrast and contrast-enhanced)
3. Patients treated at institutions designated as training hospitals by the Japan Pancreas Society
Key exclusion criteria
Any of the following:
1. Patients with acute pancreatitis or chronic pancreatitis (early chronic pancreatitis is not excluded)
2. Patients with extensive pancreatic atrophy
3. IPMN with worrisome features
4. Patients who had already undergone pancreatectomy or splenectomy prior to the pancreatic cancer diagnosis
5. Patients who received preoperative chemotherapy
6. Functional neuroendocrine tumors of the pancreas
7. Cases deemed unsuitable for fat measurement based on imaging
8. Others deemed inappropriate by the principal/sub-investigator
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | REIKO |
| Middle name | |
| Last name | ASHIDA |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL
073-447-2300
rashida@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | REIKO |
| Middle name | |
| Last name | ASHIDA |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL
073-447-2300
Homepage URL
fat-panc@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Project Research Grant, Japan Pancreas Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Wakayama Medical University
Address
811-1 Kimiidera, Wakayama City, Wakayama 641-8509, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not available
Management information
Registered date
| 2026 | Year | 04 | Month | 30 | Day |
Last modified on
| 2026 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070280
