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

NCT06608667 | Completed DMC

• 1 other identifier: XJTU1AF2021LSK-272
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation; Hyperspectral Imaging

Keywords

liver transplantation; Hyperspectral Imaging; Evaluation of donor liver; Early Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assessment of fatty liver graft 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

Study Arms (2)

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

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

Interventions

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

Mild ischemia reperfusion injury group(MIRIG); Severe ischemia reperfusion injury group(SIRIG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Study Officials

• Bo Wang, MD PhD

  First Affiliated Hospital Xian Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: September 23, 2024
• Study Start: June 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)