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临床试验/NCT05334836
NCT05334836招募中不适用

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

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2022年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
236
试验地点
2
主要终点
Prevalence of pancreatic steatosis determined by fat quantitation on MRI

研究概览

简要总结

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.

详细描述

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

The prevalence of incidentally found pancreatic cystic lesions ranges from 2.1% to 13.5% 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 and/or EUS periodically, with intervals tailored to the size of the BD-IPMN.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • 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.
  • Patients who are able to provide written informed consent to participate in the study and comply with the study procedures.

排除标准

  • Unable to provide written informed consent
  • Patients with metallic implants or other contraindications to MRI
  • Patients with contraindications for endoscopy due to comorbidities
  • Patients with known pancreatic cancer or prior pancreatic resection
  • 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

结局指标

主要结局

Prevalence of pancreatic steatosis determined by fat quantitation on MRI

时间窗: At the time of procedure

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.

次要结局

  • Prevalence of coexisting fatty liver and fatty pancreas, fatty liver alone, or fatty pancreas alone in patients with presumed IPMN or MCN(At the time of procedure)
  • Prevalence of worrisome features or high-risk stigmata on baseline EUS in patients with presumed IPMN or MCN without pancreatic steatosis(At the time of procedure)
  • Risk factors for pancreatic steatosis in patients with presumed IPMN or MCN(At the time of procedure)
  • Prevalence of worrisome features or high-risk stigmata on baseline EUS in patients with presumed IPMN or MCN and pancreatic steatosis(At the time of procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raymond Shing Yan Tang

Assitant Professor

Chinese University of Hong Kong

研究点 (2)

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