Tokyo, May 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061420) titled 'National Retrospective Survey on the Prevalence of Fatty Pancreas in Patients with Pancreatic Cancer' on May 27.
Study Type:
Observational
Primary Sponsor:
Institute - Wakayama Medical University
Condition:
Condition - Pancreatic cancer, Pancreatic neuroendocrine tumor
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 20
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 Size - 1000
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070280
Disclaimer: Curated by HT Syndication.
