Clinical trial NCT03933111: Application of Newly Developed Endoscopic Ultrasound With Zone Sonography Technology for Diagnosis of Pancreatic Caner
Official title: Application of Newly Developed Endoscopic Ultrasound With Zone Sonography Technology for Diagnosis of Pancreatic Caner: a Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Endoscopic Ultrasound
Zone Sonography Technology
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Shengjing Hospital
name: Beijing Friendship Hospital
name: Huashan Hospital
name: Sun Yat-sen University
name: Tongji Hospital
name: Shenzhen Hospital of Southern Medical University
First posted: 2019-05-01
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients aged between 18 and 75, gender is not limited.
2. Evidence of solid pancreatic lesions have been found on imaging examination, including computed tomography, magnatic resonance imaging and endoscopic ultrasonography.
3. The lesion was greater 1cm.
4. The informed consent has been signed.

Exclusion Criteria:

1. Patients with serious cardiopulmonary diseases and poor general condition.
2. Patients with other contraindications to endoscopic ultrasonography.
3. Cannot or refuse to sign the informed consent.

Primary outcomes:
measure: The threshold value of sound velocity for benign and malignant pancreatic lesions
timeFrame: up to 3 months
measure: The evaluation of the threshold value
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Department of Gastroenterology, Changhai Hospital, Second Military Medical University
name: Zhao-shen Li, M.D
role: PRINCIPAL_INVESTIGATOR
References: