The Clinical Study Aims to Assess the Quality of Donor Livers Using Hyperspectral Imaging.

The Evaluation of Ischemia-reperfusion Injury in the Donor Liver Can Be Achieved Through the Utilization of Noninvasive Near-infrared Hyperspectral Imaging.

Based on hyperspectral imaging equipment, this project collected hyperspectral imaging data of donor livers, analyzed various parameters, investigated the detection capability of hyperspectral imaging for assessing donor liver quality, gathered patient prognosis information, examined the correlation between early postoperative complications and hyperspectral imaging data, and explored characteristic parameters for evaluating donor liver quality using hyperspectral imaging technology. The occurrence of early complications was predicted.

Study Overview

• Status: Completed
• Conditions: Liver Transplantation; Hyperspectral Imaging
• Intervention / Treatment: Device: The study was retrospective and did not involve the application of interventions

Detailed Description

Hyperspectral imaging (HSI) is an advanced optical technology that combines spectroscopy and imaging, providing a non-destructive approach for clinical diagnosis. In recent years, hyperspectral imaging has emerged as a prominent research topic in the field of applied medicine. Liver transplantation is considered the most effective treatment for end-stage liver disease; however, the scarcity of donor livers and the growing number of patients awaiting transplantation pose significant challenges to global organ transplantation. The evaluation of donor livers has always been a focal point in liver transplantation. Currently, clinical evaluation relies heavily on subjective judgment by transplant physicians based on general appearance and touch assessments, along with clinical examinations and pathological biopsy results. Nevertheless, studies have demonstrated that these methods are not entirely reliable for assessing liver quality. Therefore, it is crucial to identify additional evaluation parameters and establish a convenient, reliable, and non-invasive method to assess donor liver quality. This study aims to analyze hyperspectral imaging data alongside clinical test data and recipient complications occurring between June 2022 to June 2024 to evaluate the quality of donor livers using hyperspectral imaging technology while exploring potential evaluation parameters.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xian, Shaanxi, China, 710061
      • First Affiliated Hospital Xian Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (age from 18 to 65) who underwent liver transplantation using grafts from deceased donors from June 1st, 2022 to June 30st, 2024, were retrospectively identified using Chian Liver Transplant Registry(CLTR)

, a database and official website for national data gathering and clinical data from the First Affiliated Hospital of Xi'an Jiaotong University

Description

Inclusion Criteria:

1. Recipients ranged in age from 18 to 65
2. Donor age ≥ 18 years

Exclusion Criteria:

1. Recipients are younger than 18 years or older than 65 years
2. Donor younger than 18 years
3. Secondary liver transplantation.
4. Multiple organ transplantation.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mild ischemia reperfusion injury group(MIRIG); Suzuki's score of 0 to 2 group were divided into mild ischemia-reperfusion injury group. Subjects matching the characteristics of this group were screened according to inclusion and exclusion criteria, and preoperative and postoperative characteristics of the corresponding recipients and donors were collected and recorded for subsequent analysis.	Device: The study was retrospective and did not involve the application of interventions; The study was retrospective and did not involve the application of interventions
Severe ischemia reperfusion injury group(SIRIG); Suzuki's score of 3 to 4 group were divided into severe ischemia-reperfusion injury group. Subjects matching the characteristics of this group were screened according to inclusion and exclusion criteria, and preoperative and postoperative characteristics of the corresponding recipients and donors were collected and recorded for subsequent analysis.	Device: The study was retrospective and did not involve the application of interventions; The study was retrospective and did not involve the application of interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyperspectral imaging to assess ischemia-reperfusion injury in liver grafts	Assessment of severity of ischemia-reperfusion injury of donor liver grafts by hyperspectral imaging	From June 1,2022 to June 30,2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of fatty liver graft using hyperspectral imaging	Assessing the severity of fatty liver using Hyperspectral Imaging	From June 1,2022 to June 30,2024
Hyperspectral imaging predicts early serologic markers of liver function and inflammatory factors		From June 1,2022 to June 30,2024
Assessing early allograft dysfunction after liver transplantation using hyperspectral imaging		From June 1,2022 to June 30,2024

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Chair: Bo Wang, MD PhD, First Affiliated Hospital Xian Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: liver transplantation; Hyperspectral Imaging; Evaluation of donor liver; Early Complications
• Other Study ID Numbers: XJTU1AF2021LSK-272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study was based on database from The First Affiliated Hospital of Xian Jiao Tong University , researchers did not have access to patients information or raw data unless approved by the Ethics Committee of The First Affiliated Hospital of Xian Jiao Tong University.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No