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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03933111
Enrollment
380
Registered
2019-05-01
Start date
2018-06-01
Completion date
2019-06-01
Last updated
2019-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Endoscopic Ultrasound, Zone Sonography Technology

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.

Interventions

DIAGNOSTIC_TESTlocal sound velocity measurement

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.

Sponsors

Shengjing Hospital
CollaboratorOTHER
Beijing Friendship Hospital
CollaboratorOTHER
Huashan Hospital
CollaboratorOTHER
Sun Yat-sen University
CollaboratorOTHER
Tongji Hospital
CollaboratorOTHER
Shenzhen Hospital of Southern Medical University
CollaboratorOTHER
Changhai Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The threshold value of sound velocity for benign and malignant pancreatic lesionsup to 3 monthsThe 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 valueup to 3 monthsThe 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.

Countries

China

Contacts

Primary ContactZhen-dong Jin, Ph.D
zhendjin@126.com086-13901618837
Backup ContactJie-fang Guo, M.D
jefennyst@163.com086-13022161508

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026