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

NCT ID: NCT06608667

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Liver Transplantation Hyperspectral Imaging

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

The study was retrospective and did not involve the application of interventions

Intervention Type DEVICE

The study was retrospective and did not involve the application of interventions

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.

The study was retrospective and did not involve the application of interventions

Intervention Type DEVICE

The study was retrospective and did not involve the application of interventions

Interventions

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The study was retrospective and did not involve the application of interventions

The study was retrospective and did not involve the application of interventions

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Hu Liangshuo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Wang, MD PhD

Role: STUDY_CHAIR

First Affiliated Hospital Xian Jiaotong University

Locations

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First Affiliated Hospital Xian Jiaotong University

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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XJTU1AF2021LSK-272

Identifier Type: -

Identifier Source: org_study_id

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