A Prospective Study: Smart Phone Application for Measure Serum Bilirubin Through Sclera Images

A Prospective Study: A Computer Vision Model on a Smartphone Platform for Real-time Evaluation of Serum Bilirubin Through Sclera Images

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.

Study Overview

• Status: Recruiting
• Conditions: Jaundice; Hyperbilirubinemia; Deep Learning; Sclera

• Study Type: Observational
• Enrollment (Estimated): 270

Contacts and Locations

• Study Contact: Name: Yanglin Pan, MD; Phone Number: 86-13991811225; Email: yanglinpan@hotmail.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • First Affiliated Hospital of Air Force Military Medical University
      • Contact: Yanglin Pan; Phone Number: 13991811225; Email: yanglinpan@hotmail.com
      • Sub-Investigator: Xintain Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Study Population Description:

The study will include a total of 270 patients, both male and female, aged 14 years and above. The participants should not have any pre-existing conditions that may affect the color of their sclera. They should be able to follow instructions and complete the scleral imaging procedure. The patient population will primarily consist of individuals undergoing treatment for colorectal polyps, pancreatitis, pancreatic tumors, hepatobiliary stones, or biliary tract tumors.

Screening Procedure:

Potential participants will be screened using oral queries to assess their eligibility based on the inclusion and exclusion criteria. A brief ocular examination will be performed to rule out any apparent ocular surface disorders. Eligible participants will be provided with a detailed explanation of the study objectives, procedures, and potential risks and benefits. Written informed consent will be obtained from all participants prior to enrollment in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Real-Time Scleral Jaundice Evaluation in Gastroenterology Cohort; The cohort consists of at least 270 subjects consecutively enrolled from the Department of Gastroenterology at Xijing Hospital. The subjects will be followed prospectively over a period of time to collect data on their age, medical information, scleral images, and liver function test results. The cohort includes patients with various liver diseases and varying degrees of jaundice severity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Classification accuracy	Classification accuracy for the jaundice severity grading model	Immediately after test completion

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2024
• Primary Completion (Estimated): June 20, 2024
• Study Completion (Estimated): July 10, 2024

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Hyperbilirubinemia; Real-time; Deep learning; Smart phone; Sclera
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Manifestations; Jaundice; Hyperbilirubinemia
• Other Study ID Numbers: KY20242031-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No