Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05334836
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2022-04-07
Brief Title:
Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FPPCN
Brief Summary:
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 940 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 29 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 andor 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 andor EUS to identify high-risk neoplastic progression indicated for surgical resection
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 29 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 andor 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 andor EUS to identify high-risk neoplastic progression indicated for surgical resection
Detailed Description:
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 940 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 29 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 andor 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 andor EUS to identify high-risk neoplastic progression indicated for surgical resection
The prevalence of incidentally found pancreatic cystic lesions ranges from 21 to 135 in patients undergoing CT or MRI for non-pancreatic indications In patients with pre-malignant mucinous PCN intraductal papillary mucinous neoplasms IPMN and mucinous cystic neoplasms MCN pancreatic cancer can originate from the pre-malignant PCN or develop in other parts of the pancreas uninvolved by the original PCN due to field-defect While the malignant potentials of different PCNs vary the frequency of invasive carcinoma and high-grade dysplasia in IPMN remains substantial ranging from 36-100 in the main duct type MD-IPMN and from 14-48 in the branch duct type BD-IPMN
Multiple consensus guidelines and society guidelines have been developed based on cyst structural characteristics and cyst related symptoms to guide management between surgical resection or surveillance of pre-malignant PCN The 2017 revised international consensus guidelines Fukuoka guidelines recommend surgical resection for all MD-IPMN and BD-IPMN with high-risk stigmata of malignancy or worrisome features confirmed by EUS definite mural nodule 5mm main pancreatic duct involvement dilation abrupt change in calibre cytology suspicious or positive for malignancy on EUS guided fine needle aspiration On the other hand surveillance of asymptomatic BD-IPMN without high-risk stigmata or worrisome features would be performed with cross-sectional imaging andor EUS periodically with intervals tailored to the size of the BD-IPMN
Although the consensus guidelines and society guidelines have been widely applied in clinical practice considerable variations in their sensitivity specificity positive and negative predictive values in predicting advanced neoplasia high-grade dysplasia and invasive cancer in pre-malignant PCN were reported in validation studies As such false-positive recommending patients with low-risk PCN for a major surgery with considerable risks of morbidity mortality or false-negative missing a high-risk PCN with indication for surgery to prevent cancer development prediction of malignant progression of mucinous PCN can still occur with significant clinical ramification In addition while cyst structural characteristics are traditional risk factors for neoplastic progression of PCN these are not easily modifiable unless invasive procedures such as surgical resection or cyst ablation is performed Therefore it is of clinical importance to identify novel risk factors in pancreas that are potentially modifiable and may improve the current risk stratification algorithm for detection of high-risk lesions
Pancreatic steatosis is an increasingly recognized important metabolic condition with a prevalence of 16 to 35 in Asian populations Recent retrospective studies have suggested an increased risk of pancreatic cancer IPMN and progression of BD-IPMN in patients with pancreatic steatosis However despite its potential role as a modifiable risk factor for pancreatic cancer and progression of pre-malignant PCN such as IPMN the actual prevalence of pancreatic steatosis in patients with PCN is not known
While ultrasound CT and MRI have been used for fat quantitation in organs MRI is best suited for this purpose since its signal is dependent on fat content In contrast to fat content assessment by ultrasound in which interobserver variability may undermine its reliability the fat fraction measurements by MRI are reproducible and accurate and have been validated against histology in animal models In addition MRI also has an advantage over CT since there is no risk of radiation exposure
Previous work by our group has defined the normal range of fat content in pancreas 18 -104 in the healthy Hong Kong population using MRI for fat quantification The prevalence of fatty pancreas in healthy volunteers was found to be 161 when a pancreatic fat upper limit of normal of 104 was adopted Our group has also shown that patients with fatty liver do not always have fatty pancreas Among the 195 patients with fatty liver in our prior study 82195 421 had both fatty liver and fatty pancreas and 113195 579 had fatty liver alone Such observation suggested that pancreatic steatosis is likely a separate metabolic condition that deserves further investigation for its potential impact on important pancreatic pathologies such as pre-malignant PCN eg IPMN and pancreatic cancer
Because little is known about the prevalence of pancreatic steatosis in patients with PCN we would like to propose a prospective matched case-control study to determine the prevalence of pancreatic steatosis using MRI in patients with presumed IPMN or MCN and compare with that of age and sex matched healthy subjects in the general population
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 29 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 andor 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 andor EUS to identify high-risk neoplastic progression indicated for surgical resection
The prevalence of incidentally found pancreatic cystic lesions ranges from 21 to 135 in patients undergoing CT or MRI for non-pancreatic indications In patients with pre-malignant mucinous PCN intraductal papillary mucinous neoplasms IPMN and mucinous cystic neoplasms MCN pancreatic cancer can originate from the pre-malignant PCN or develop in other parts of the pancreas uninvolved by the original PCN due to field-defect While the malignant potentials of different PCNs vary the frequency of invasive carcinoma and high-grade dysplasia in IPMN remains substantial ranging from 36-100 in the main duct type MD-IPMN and from 14-48 in the branch duct type BD-IPMN
Multiple consensus guidelines and society guidelines have been developed based on cyst structural characteristics and cyst related symptoms to guide management between surgical resection or surveillance of pre-malignant PCN The 2017 revised international consensus guidelines Fukuoka guidelines recommend surgical resection for all MD-IPMN and BD-IPMN with high-risk stigmata of malignancy or worrisome features confirmed by EUS definite mural nodule 5mm main pancreatic duct involvement dilation abrupt change in calibre cytology suspicious or positive for malignancy on EUS guided fine needle aspiration On the other hand surveillance of asymptomatic BD-IPMN without high-risk stigmata or worrisome features would be performed with cross-sectional imaging andor EUS periodically with intervals tailored to the size of the BD-IPMN
Although the consensus guidelines and society guidelines have been widely applied in clinical practice considerable variations in their sensitivity specificity positive and negative predictive values in predicting advanced neoplasia high-grade dysplasia and invasive cancer in pre-malignant PCN were reported in validation studies As such false-positive recommending patients with low-risk PCN for a major surgery with considerable risks of morbidity mortality or false-negative missing a high-risk PCN with indication for surgery to prevent cancer development prediction of malignant progression of mucinous PCN can still occur with significant clinical ramification In addition while cyst structural characteristics are traditional risk factors for neoplastic progression of PCN these are not easily modifiable unless invasive procedures such as surgical resection or cyst ablation is performed Therefore it is of clinical importance to identify novel risk factors in pancreas that are potentially modifiable and may improve the current risk stratification algorithm for detection of high-risk lesions
Pancreatic steatosis is an increasingly recognized important metabolic condition with a prevalence of 16 to 35 in Asian populations Recent retrospective studies have suggested an increased risk of pancreatic cancer IPMN and progression of BD-IPMN in patients with pancreatic steatosis However despite its potential role as a modifiable risk factor for pancreatic cancer and progression of pre-malignant PCN such as IPMN the actual prevalence of pancreatic steatosis in patients with PCN is not known
While ultrasound CT and MRI have been used for fat quantitation in organs MRI is best suited for this purpose since its signal is dependent on fat content In contrast to fat content assessment by ultrasound in which interobserver variability may undermine its reliability the fat fraction measurements by MRI are reproducible and accurate and have been validated against histology in animal models In addition MRI also has an advantage over CT since there is no risk of radiation exposure
Previous work by our group has defined the normal range of fat content in pancreas 18 -104 in the healthy Hong Kong population using MRI for fat quantification The prevalence of fatty pancreas in healthy volunteers was found to be 161 when a pancreatic fat upper limit of normal of 104 was adopted Our group has also shown that patients with fatty liver do not always have fatty pancreas Among the 195 patients with fatty liver in our prior study 82195 421 had both fatty liver and fatty pancreas and 113195 579 had fatty liver alone Such observation suggested that pancreatic steatosis is likely a separate metabolic condition that deserves further investigation for its potential impact on important pancreatic pathologies such as pre-malignant PCN eg IPMN and pancreatic cancer
Because little is known about the prevalence of pancreatic steatosis in patients with PCN we would like to propose a prospective matched case-control study to determine the prevalence of pancreatic steatosis using MRI in patients with presumed IPMN or MCN and compare with that of age and sex matched healthy subjects in the general population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None