Application of Newly Developed Endoscopic Ultrasound With Zone Sonography Technology for Diagnosis of Pancreatic Caner: a Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- The threshold value of sound velocity for benign and malignant pancreatic lesions
研究概览
简要总结
The purpose of this study is to measure and compare the difference of sound speed between pancreatic cancer and non-pancreatic cancer, and determine the critical value of sound speed for benign and malignant pancreatic cancer. The sensitivity, specificity, accuracy, positive predictive value and negative predictive value for the diagnosis of pancreatic cancer are calculated, so as to evaluate the clinical application value of local sound speed measurement in the diagnosis of pancreatic cancer.
详细描述
The investigators include patients who are found to have solid pancreatic mass on continuous imaging. All subjects are scanned by Fuji film su-9000 ultrasonic system. After the lesions are found, local sound velocity measurement technology will be used to measure the sound velocity in the lesions. Pathology diagnosis or clinical follow-up results will be regard as diagnostic gold standard to divide the patients into pancreatic cancer and pancreatic cancer group. The investigators will compare the sound velocity value if there is statistically significant difference between the two groups, build the receiver operating characteristic curve, calculation of pancreatic benign and malignant lesions of sound velocity threshold, and and the investigators will calculate the sensitivity, specificity, accuracy, positive predictive value and negative predictive value, to evaluate local sound velocity measurement in the diagnosis of pancreatic cancer clinical application value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 18 and 75, gender is not limited.
- •Evidence of solid pancreatic lesions have been found on imaging examination, including computed tomography, magnatic resonance imaging and endoscopic ultrasonography.
- •The lesion was greater 1cm.
- •The informed consent has been signed.
排除标准
- •Patients with serious cardiopulmonary diseases and poor general condition.
- •Patients with other contraindications to endoscopic ultrasonography.
- •Cannot or refuse to sign the informed consent.
研究组 & 干预措施
patients with pancreatic solid neoplasms
Patients with pancreatic solid neoplasms are enrolled in this study and accept the test.
干预措施: local sound velocity measurement (Diagnostic Test)
结局指标
主要结局
The threshold value of sound velocity for benign and malignant pancreatic lesions
时间窗: up to 3 months
The participants will compare the sound velocity value if there is statistically significant difference between the two groups, build the Receiver Operating Characteristic curve, determine the threshold value of sound velocity for benign and malignant pancreatic lesions.
The evaluation of the threshold value
时间窗: up to 3 months
The participants will calculate the sensitivity, specificity, accuracy, positive predictive value and negative predictive value, to evaluate local sound velocity measurement in the diagnosis of pancreatic cancer clinical application value.
次要结局
未报告次要终点
研究者
Zhaoshen Li
Director of Gastroenterology Department
Changhai Hospital