Pancreatic Cyst Clinical Trial
— FPPCNOfficial title:
Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features in Patients With Pre-malignant Pancreatic Cystic Neoplasms Using Magnetic Resonance Imaging and Endoscopic Ultrasound
Pancreatic cancer is the fifth leading cause of cancer mortality in Hong Kong and the seventh leading cause of cancer mortality worldwide. In 2020, approximately 496000 new cases of pancreatic cancers were diagnosed globally . Pancreatic cancer is a highly fatal cancer with a case-fatality rate of 94.0% globally. In Hong Kong, both the incidence and mortality of pancreatic cancer have increased over the past decade. Due to the deep-seated location of pancreas, it is difficult to diagnose pancreatic cancer at an early stage, which in turn leads to delays in cancer treatment and poorer survival. Despite advances in oncologic treatment, the 5-year survival rate of metastatic pancreatic cancer remains poor (~2.9%). As such, there has been growing interest to improve pancreatic cancer prevention and survival by: 1. reduction of modifiable risk factors (eg, cigarette smoking, obesity, diabetes), 2. screening for early detection of high-risk pre-malignant lesions in selected high-risks patients with strong family history of pancreatic cancer and/or certain germline mutations of pancreatic cancer susceptibility genes (eg, BRCA1, BRAC2, DNA mismatch repair genes in Lynch Syndrome, etc) by magnetic resonance imaging (MRI) or endoscopic ultrasound (EUS), and 3. surveillance of pre-malignant precursor lesions such as mucinous pancreatic cystic neoplasms (PCN) by imaging and/or EUS to identify high-risk neoplastic progression indicated for surgical resection.
Status | Recruiting |
Enrollment | 236 |
Est. completion date | December 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age 18 or older 2. Patients with at least 1 pancreatic cystic lesion presumed to be IPMN or MCN based on CT, MRI or EUS features, with a cyst size = 5mm; or healthy subjects. 3. Patients who are able to provide written informed consent to participate in the study and comply with the study procedures. Exclusion Criteria: 1. Unable to provide written informed consent 2. Patients with metallic implants or other contraindications to MRI 3. Patients with contraindications for endoscopy due to comorbidities 4. Patients with known pancreatic cancer or prior pancreatic resection 5. 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital, The Chinese University of Hong Kong | Sha Tin | New Territories |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of pancreatic steatosis determined by fat quantitation on MRI | Prevalence of pancreatic steatosis will be determined in patients with presumed IPMN or MCN and in age and sex matched healthy subjects in the general population. | At the time of procedure | |
Secondary | Prevalence of worrisome features or high-risk stigmata on baseline EUS in patients with presumed IPMN or MCN and pancreatic steatosis | worrisome features or high-risk stigmata are defined according to 2017 revised Fukuoka international consensus guidelines | At the time of procedure | |
Secondary | Prevalence of worrisome features or high-risk stigmata on baseline EUS in patients with presumed IPMN or MCN without pancreatic steatosis | worrisome features or high-risk stigmata are defined according to 2017 revised Fukuoka international consensus guidelines | At the time of procedure | |
Secondary | Prevalence of coexisting fatty liver and fatty pancreas, fatty liver alone, or fatty pancreas alone in patients with presumed IPMN or MCN | Diagnosis of fatty liver, fatty pancreas will be based on fat quantitation on MRI | At the time of procedure | |
Secondary | Risk factors for pancreatic steatosis in patients with presumed IPMN or MCN | Regression analysis will be used to help identify risk factors for pancreatic steatosis | At the time of procedure |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05572788 -
Rectal Indomethacin to Prevent Acute Pancreatitis in EUS-FNA of Pancreatic Cysts
|
N/A | |
Not yet recruiting |
NCT06320990 -
Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection
|
Phase 1 | |
Completed |
NCT01770405 -
Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract
|
N/A | |
Completed |
NCT01643460 -
Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts
|
N/A | |
Recruiting |
NCT03260842 -
Bio-Repository of High Risk Cohorts for the Early Detection of Pancreas Cancer
|
||
Recruiting |
NCT04291651 -
UCSF PANC Cyst Registry
|
||
Recruiting |
NCT05692596 -
The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics
|
||
Recruiting |
NCT03334708 -
A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
|
||
Recruiting |
NCT04140435 -
EUS-guided Through-the-needle Microforceps Biopsy Outcomes
|
||
Terminated |
NCT00550108 -
Management of Incidentally Discovered Pancreatic Cysts
|
Phase 3 | |
Recruiting |
NCT03492151 -
Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
|
||
Completed |
NCT03169842 -
Cyst Fluid Glucose for On-site Diagnosis of Mucinous Pancreatic Cysts
|
N/A | |
Recruiting |
NCT04404101 -
Evaluation of Pancreatic Cystic Lesions Via EUS-guided Fine Needle Aspiration With and Without Micro Forceps Biopsies
|
N/A | |
Recruiting |
NCT06305728 -
A Study of Early Cancer Detection in People at High Risk of Developing Pancreatic Ductal Adenocarcinoma (PDAC)
|
||
Recruiting |
NCT06340620 -
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
|
N/A | |
Recruiting |
NCT02343692 -
A Phase II Multicentre Trial of Endoscopic Ultrasound Guided Radiofrequency Ablation of Cystic Tumours of the Pancreas
|
N/A | |
Recruiting |
NCT02775461 -
Pancreas Registry and High Risk Registry
|
||
Active, not recruiting |
NCT01563133 -
Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas
|
N/A | |
Completed |
NCT00222898 -
Cancer Detection in Pancreatic Cysts
|
N/A | |
Not yet recruiting |
NCT06276764 -
The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)
|