Clinical trial NCT06608667: The Clinical Study Aims to Assess the Quality of Donor Livers Using Hyperspectral Imaging.
Official title: The Evaluation of Ischemia-reperfusion Injury in the Donor Liver Can Be Achieved Through the Utilization of Noninvasive Near-infrared Hyperspectral Imaging.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Hyperspectral Imaging
Keywords: liver transplantation
Hyperspectral Imaging
Evaluation of donor liver
Early Complications
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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\&#39;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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hyperspectral imaging to assess ischemia-reperfusion injury in liver grafts
timeFrame: From June 1,2022 to June 30,2024
Secondary outcomes:
measure: Assessment of fatty liver graft using hyperspectral imaging
timeFrame: From June 1,2022 to June 30,2024
measure: Hyperspectral imaging predicts early serologic markers of liver function and inflammatory factors
timeFrame: From June 1,2022 to June 30,2024
measure: Assessing early allograft dysfunction after liver transplantation using hyperspectral imaging
timeFrame: From June 1,2022 to June 30,2024
Other outcomes:
Locations:
city: Xian
country: China
facility: First Affiliated Hospital Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xian Jiaotong University
name: Bo Wang, MD PhD
role: STUDY_CHAIR
References: