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出境医 / 临床实验 / 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

Study Description
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Diagnostic Test: local sound velocity measurement Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Application of Newly Developed Endoscopic Ultrasound With Zone Sonography Technology for Diagnosis of Pancreatic Caner: a Prospective Multicenter Study
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: patients with pancreatic solid neoplasms
Patients with pancreatic solid neoplasms are enrolled in this study and accept the test.
 Diagnostic Test: 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.
Outcome Measures
Primary Outcome Measures :
  1. The threshold value of sound velocity for benign and malignant pancreatic lesions [ Time Frame: 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.

  2. The evaluation of the threshold value [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Contacts
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Contact: Zhen-dong Jin, Ph.D 086-13901618837 zhendjin@126.com
Contact: Jie-fang Guo, M.D 086-13022161508 jefennyst@163.com

Locations
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China, Shanghai
Changhai Hospital Recruiting
Shanghai, Shanghai, China, 210000
Contact: Zhen-dong Jin, Ph.D    13901618837    zhendjin@126.com   
Sponsors and Collaborators
Changhai Hospital
Shengjing Hospital
Beijing Friendship Hospital
Huashan Hospital
Sun Yat-sen University
Tongji Hospital
Shenzhen Hospital of Southern Medical University
Investigators
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Principal Investigator: Zhao-shen Li, M.D Department of Gastroenterology, Changhai Hospital, Second Military Medical University
Tracking Information
First Submitted Date  ICMJE April 9, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date May 1, 2019
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2019)
  • The threshold value of sound velocity for benign and malignant pancreatic lesions [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Application of Newly Developed Endoscopic Ultrasound With Zone Sonography Technology for Diagnosis of Pancreatic Caner
Official Title  ICMJE Application of Newly Developed Endoscopic Ultrasound With Zone Sonography Technology for Diagnosis of Pancreatic Caner: a Prospective Multicenter Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Diagnostic Test: 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.
Study Arms  ICMJE Experimental: patients with pancreatic solid neoplasms
Patients with pancreatic solid neoplasms are enrolled in this study and accept the test.
Intervention: Diagnostic Test: local sound velocity measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 28, 2019) 		380
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03933111
Other Study ID Numbers  ICMJE shengsu
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zhaoshen Li, Changhai Hospital
Study Sponsor  ICMJE Changhai Hospital
Collaborators  ICMJE
  • Shengjing Hospital
  • Beijing Friendship Hospital
  • Huashan Hospital
  • Sun Yat-sen University
  • Tongji Hospital
  • Shenzhen Hospital of Southern Medical University
Investigators  ICMJE
Principal Investigator: Zhao-shen Li, M.D Department of Gastroenterology, Changhai Hospital, Second Military Medical University
PRS Account Changhai Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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