Liver TransplantationNCT06608667
The Clinical Study Aims to Assess the Quality of Donor Livers Using Hyperspectral Imaging.
An observational study of Liver Transplantation and Hyperspectral Imaging, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation, Hyperspectral Imaging
- What is being tested?
- The study was retrospective and did not involve the application of interventions
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Recipients ranged in age from 18 to 65
- Donor age ≥ 18 years
Who cannot join
- Recipients are younger than 18 years or older than 65 years
- Donor younger than 18 years
- Secondary liver transplantation.
- Multiple organ transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital Xian Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: The Evaluation of Ischemia-reperfusion Injury in the Donor Liver Can Be Achieved Through the Utilization of Noninvasive Near-infrared 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.
Read the 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.
- Conditions
- Liver Transplantation, Hyperspectral Imaging
- Being tested
- The study was retrospective and did not involve the application of interventions
- Keywords
- liver transplantation, Hyperspectral Imaging, Evaluation of donor liver, Early Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The study was retrospective and did not involve the application of interventionsDevice
The study was retrospective and did not involve the application of interventions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: The study was retrospective and did not involve the application of interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperspectral imaging to assess ischemia-reperfusion injury in liver grafts
Assessment of severity of ischemia-reperfusion injury of donor liver grafts by hyperspectral imaging
Measured: From June 1,2022 to June 30,2024
Secondary outcomes (3)
Assessment of fatty liver graft using hyperspectral imaging
Assessing the severity of fatty liver using Hyperspectral Imaging
Measured: From June 1,2022 to June 30,2024
Hyperspectral imaging predicts early serologic markers of liver function and inflammatory factors
Measured: From June 1,2022 to June 30,2024
Assessing early allograft dysfunction after liver transplantation using hyperspectral imaging
Measured: From June 1,2022 to June 30,2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Jun 2022
- Primary completion30 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Liangshuo, First Affiliated Hospital Xi'an Jiaotong University
- Investigators
- Bo Wang, MD PhD, Study chair, First Affiliated Hospital Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608667
- Sponsor's protocol ID
- XJTU1AF2021LSK-272
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study was based on database from The First Affiliated Hospital of Xian Jiao Tong University , researchers did not have access to patients information or raw data unless approved by the Ethics Committee of The First Affiliated Hospital of Xian Jiao Tong University.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Ischemia-reperfusion Injury in the Donor Liver Can Be Achieved Through the Utilization of Noninvasive Near-infrared Hyperspectral Imaging.
- ClinicalTrials.gov ID
- NCT06608667
- Acronym / sponsor ID
- XJTU1AF2021LSK-272
- Conditions
- Liver Transplantation, Hyperspectral Imaging
- Keywords
- liver transplantation, Hyperspectral Imaging, Evaluation of donor liver, Early Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild ischemia reperfusion injury group(MIRIG) | – | Device: The study was retrospective and did not involve the application of interventionsSuzuki'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) | – | Device: The study was retrospective and did not involve the application of interventionsSuzuki'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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Recipients ranged in age from 18 to 65
- Donor age ≥ 18 years
Key exclusion criteria (4 listed)
- Recipients are younger than 18 years or older than 65 years
- Donor younger than 18 years
- Secondary liver transplantation.
- Multiple organ transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The study was retrospective and did not involve the application of interventionsThe study was retrospective and did not involve the application of interventions | Device | Mild ischemia reperfusion injury group(MIRIG), Severe ischemia reperfusion injury group(SIRIG) |
Primary outcome
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
3 secondary outcomes
Assessment of fatty liver graft using hyperspectral imaging
Time frame: From June 1,2022 to June 30,2024
Hyperspectral imaging predicts early serologic markers of liver function and inflammatory factors
Time frame: From June 1,2022 to June 30,2024
Assessing early allograft dysfunction after liver transplantation using hyperspectral imaging
Time frame: From June 1,2022 to June 30,2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No. The study was based on database from The First Affiliated Hospital of Xian Jiao Tong University , researchers did not have access to patients information or raw data unless approved by the Ethics Committee of The First Affiliated Hospital of Xian Jiao Tong University.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Wang, MD PhD study chair
First Affiliated Hospital Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation and Hyperspectral Imaging, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperspectral imaging to assess ischemia-reperfusion injury in liver grafts (time frame: From June 1,2022 to June 30,2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.