Application of Newly Developed Endoscopic Ultrasound With Zone Sonography Technology for Diagnosis of Pancreatic Caner

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Application of Newly Developed Endoscopic Ultrasound With Zone Sonography Technology for Diagnosis of Pancreatic Caner: a Prospective Multicenter Study

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Diagnostic Test: local sound velocity measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients with serious cardiopulmonary diseases and poor general condition. Patients with other contraindications to endoscopic ultrasonography. Cannot or refuse to sign the informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with pancreatic solid neoplasms<br>Patients with pancreatic solid neoplasms are enrolled in this study and accept the test. | Diagnostic Test: local sound velocity measurement<br>* All patients 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 divide the patients into pancreatic cancer and pancreatic cancer group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The threshold value of sound velocity for benign and malignant pancreatic lesions | 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. | up to 3 months | 
| The evaluation of the threshold value | 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. | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Ultrasound, Zone Sonography Technology