Clinical Research on a Noval Deep-learning Based System in Benign and Malignant Pancreatic Masses Diagnosing Under Harmonic Contrast-enhanced Endoscopic Ultrasound
Sponsor study identifier
interventional
100
1 country
1
Study Start
January 1, 2020
Actual (reported)Primary Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
In this study, a single-center, prospective, self-control, and blind design was adopted.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2020
Actual (reported)October 18, 2020
Actual (reported)October 29, 2020
Actual (reported)December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
accuracy
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
1 year
sensitivity
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
1 year
specificity
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
1 year
positive predictive value
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
1 year
negative predictive value
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
1 year
the diagnosis rate of first needle aspiration
compared the diagnosis rate of AI-EUS-FNA and artificial-EUS-FNA first needle aspiration for benign and malignant pancreatic masses
1 year
core tissue length
1 year
the first two passes were made without the AI-assisted diagnosis system guidance during EUS-FNA, and then two passes were made under guidance from the AI-assisted diagnosis system
the first two passes were made with the AI-assisted diagnosis system guidance and then another two manual passes without the AI-assisted diagnosis system guidance.
The ultrasound endoscopists manually determined the region of interest (ROI) according to CH-EUS, and punctured 2 needles in the tumor area with a 22G needle, and each needle moved 15-20 times back and forth in the lesion. After puncture, insert the needle core, rinse the needle with 0.1ml sterile saline, and further apply air flushing to ensure that each tissue is sent to the slide.
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
Tang A, Tian L, Gao K, Liu R, Hu S, Liu J, Xu J, Fu T, Zhang Z, Wang W, Zeng L, Qu W, Dai Y, Hou R, Tang S, Wang X. Contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) MASTER: A novel deep learning-based system in pancreatic mass diagnosis. Cancer Med. 2023 Apr;12(7):7962-7973. doi: 10.1002/cam4.5578. Epub 2023 Jan 6.
Li Tian, MD
The Third Xiangya Hospital of Central South University
Anliu Tang, MD
The Third Xiangya Hospital of Central South University
First Submitted
October 18, 2020
First Posted
October 29, 2020
Study Start
January 1, 2020
Actual (reported)Primary Completion
December 31, 2021
Estimated (date passed)In the AI-assisted diagnosis system, the assisted targeting EUS-FNA unit is applied, and the ultrasound endoscopist selects the region of interest (ROI) according to the thermogram to perform targeted EUS-FNA puncture(2 needles in the same way).
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 29, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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