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

NCT03933111 | Unknown DMC

• 1 other identifier: shengsu
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Endoscopic Ultrasound; Zone Sonography Technology

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

patients with pancreatic solid neoplasms

EXPERIMENTAL

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

Diagnostic Test: local sound velocity measurement

Interventions

local sound velocity measurement 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.

patients with pancreatic solid neoplasms

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Changhai Hospital: lead
• Shengjing Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• Huashan Hospital: collaborator
• Sun Yat-sen University: collaborator
• Tongji Hospital: collaborator
• Shenzhen Hospital of Southern Medical University: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 210000, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Zhao-shen Li, M.D

  Department of Gastroenterology, Changhai Hospital, Second Military Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen-dong Jin, Ph.D

CONTACT

086-13901618837; zhendjin@126.com

Jie-fang Guo, M.D

CONTACT

086-13022161508; jefennyst@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology Department

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: May 1, 2019
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)