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

NCT ID: NCT03933111

Last Updated: 2019-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-06-01

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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patients with pancreatic solid neoplasms

Patients with pancreatic solid neoplasms are enrolled in this study and accept the test.

Group Type EXPERIMENTAL

local sound velocity measurement

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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local 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shengjing Hospital

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Shenzhen Hospital of Southern Medical University

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Director of Gastroenterology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhao-shen Li, M.D

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Changhai Hospital, Second Military Medical University

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhen-dong Jin, Ph.D

Role: CONTACT

086-13901618837

Jie-fang Guo, M.D

Role: CONTACT

086-13022161508

Facility Contacts

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Zhen-dong Jin, Ph.D

Role: primary

13901618837

Other Identifiers

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shengsu

Identifier Type: -

Identifier Source: org_study_id

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