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Completed

NCT Number: NCT06608667

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recipients ranged in age from 18 to 65
  • Donor age ≥ 18 years

Exclusion criteria

  • Recipients are younger than 18 years or older than 65 years
  • Donor younger than 18 years
  • Secondary liver transplantation.
  • Multiple organ transplantation.

Treatment and study plan

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

Device

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

Primary outcomes

  1. Hyperspectral imaging to assess ischemia-reperfusion injury in liver grafts

    Time frame: From June 1,2022 to June 30,2024

    Assessment of severity of ischemia-reperfusion injury of donor liver grafts by hyperspectral imaging

Secondary outcomes

  1. Assessment of fatty liver graft using hyperspectral imaging

    Time frame: From June 1,2022 to June 30,2024

    Assessing the severity of fatty liver using Hyperspectral Imaging

  2. Hyperspectral imaging predicts early serologic markers of liver function and inflammatory factors

    Time frame: From June 1,2022 to June 30,2024

  3. Assessing early allograft dysfunction after liver transplantation using hyperspectral imaging

    Time frame: From June 1,2022 to June 30,2024

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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