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

Completed

• Conditions: Hyperspectral Imaging; Liver Transplantation
• Interventions: Device: The study was retrospective and did not involve the application of interventions

• Registration Number: NCT06608667
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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.

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 Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-12-30
• Status Verified: 2024-06
• Study First Submitted: 2024-06-11
• Study Completion: 2024-06-30
• Study First Submitted QC: 2024-09-19
• Last Update Submitted: 2024-09-19
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild ischemia reperfusion injury group(MIRIG)	The study was retrospective and did not involve the application of interventions	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.
Severe ischemia reperfusion injury group(SIRIG)	The study was retrospective and did not involve the application of interventions	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assessment of fatty liver graft using hyperspectral imaging	From June 1,2022 to June 30,2024	Assessing the severity of fatty liver using Hyperspectral Imaging
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

Trial Locations

Locations (1)

First Affiliated Hospital Xian Jiaotong University; 🇨🇳 Xian, Shaanxi, China