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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06421844
Other study ID # KY20242031-F-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 20, 2024
Est. completion date July 10, 2024

Study information

Verified date May 2024
Source Air Force Military Medical University, China
Contact Yanglin Pan, MD
Phone 86-13991811225
Email yanglinpan@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The primary efficacy endpoints are the standard deviation and coefficient of determination (R2) between predicted and actual values for the bilirubin regression model, and the grading accuracy for the jaundice severity classification model. The secondary efficacy endpoint is the mean percentage error between predicted and actual bilirubin values. There are no relevant safety risks. Statistical differences for categorical variables (e.g., jaundice grading evaluation indicators) will be analyzed using the chi-square test or Fisher's exact probability test. For continuous variables (e.g., bilirubin prediction evaluation indicators), t-tests (normal distribution) or non-parametric tests (non-normal distribution) will be used. The 95% confidence interval for jaundice grading accuracy will be calculated using the Wilson method. The study duration is estimated to be 3 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 270
Est. completion date July 10, 2024
Est. primary completion date June 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria: Age 14 years or older. Subjects who are visiting the Gastroenterology Department of Xijing Hospital and will undergo liver function tests on the same day. The disease spectrum of the subjects mainly includes pancreatitis, pancreatic tumors, hepatobiliary stones, biliary tumors, and colonic polyps. Exclusion Criteria: Subjects with diseases that may cause abnormal changes in scleral color, such as glaucoma, Wilson's disease, pterygium, or scleritis. Subjects who have recently consumed a large amount of carotenoid-rich foods (such as oranges or carrots). Subjects who are unable to provide informed consent. Elimination Criteria: Subjects with incomplete scleral exposure due to limited eye movement or excessive tension during external eye examination. Subjects who are unable to understand the instructions for eye rotation during scleral examination or are unable to cooperate due to reasons such as poor hearing.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China First Affiliated Hospital of Air Force Military Medical University Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (6)

Bang JY, Navaneethan U, Hasan M, Hawes R, Varadarajulu S. Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomized trial (with videos). Gastrointest Endosc. 2018 Jul;88(1):9-17. doi: 10.1016/j.gie.2018.03.012. Epub 2018 Mar 21. — View Citation

Bian Y, Zheng Z, Fang X, Jiang H, Zhu M, Yu J, Zhao H, Zhang L, Yao J, Lu L, Lu J, Shao C. Artificial Intelligence to Predict Lymph Node Metastasis at CT in Pancreatic Ductal Adenocarcinoma. Radiology. 2023 Jan;306(1):160-169. doi: 10.1148/radiol.220329. Epub 2022 Sep 6. — View Citation

Inamori G, Kamoto U, Nakamura F, Isoda Y, Uozumi A, Matsuda R, Shimamura M, Okubo Y, Ito S, Ota H. Neonatal wearable device for colorimetry-based real-time detection of jaundice with simultaneous sensing of vitals. Sci Adv. 2021 Mar 3;7(10):eabe3793. doi: 10.1126/sciadv.abe3793. Print 2021 Mar. — View Citation

Park JH, Yang MJ, Kim JS, Park B, Kim JH, Sunwoo MH. Deep-Learning-Based Smartphone Application for Self-Diagnosis of Scleral Jaundice in Patients with Hepatobiliary and Pancreatic Diseases. J Pers Med. 2021 Sep 18;11(9):928. doi: 10.3390/jpm11090928. — View Citation

Wu HL, Yao LW, Shi HY, Wu LL, Li X, Zhang CX, Chen BR, Zhang J, Tan W, Cui N, Zhou W, Zhang JX, Xiao B, Gong RR, Ding Z, Yu HG. Validation of a real-time biliopancreatic endoscopic ultrasonography analytical device in China: a prospective, single-centre, randomised, controlled trial. Lancet Digit Health. 2023 Nov;5(11):e812-e820. doi: 10.1016/S2589-7500(23)00160-7. Epub 2023 Sep 27. — View Citation

Xiao W, Huang X, Wang JH, Lin DR, Zhu Y, Chen C, Yang YH, Xiao J, Zhao LQ, Li JO, Cheung CY, Mise Y, Guo ZY, Du YF, Chen BB, Hu JX, Zhang K, Lin XS, Wen W, Liu YZ, Chen WR, Zhong YS, Lin HT. Screening and identifying hepatobiliary diseases through deep learning using ocular images: a prospective, multicentre study. Lancet Digit Health. 2021 Feb;3(2):e88-e97. doi: 10.1016/S2589-7500(20)30288-0. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Loss of predicted bilirubin levels Standard deviation and mean average percentage error between predicted and actual bilirubin levels for the bilirubin regression model. Immediately after test completion
Primary Classification accuracy Classification accuracy for the jaundice severity grading model Immediately after test completion
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