Living Donor Liver TransplantationNCT05506020
Application of ICG Fluorescence Cholangiography in Laparoscopic Living Donor Left Lateral Sectionectomy
A study testing indocyanine green (ICG) fluorescence cholangiography in people with Living Donor Liver Transplantation, run by Fudan University.
Trial summary
The purpose of this study was to assess the effects of indocyanine green (ICG) fluorescence cholangiography during laparoscopic left lateral sectionectomy (LLLS) on the occurrence of biliary complications in both donors and recipients in living donor liver transplantation (LDLT) and to explore the optimal dose and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Living Donor Liver Transplantation
- What is being tested?
- indocyanine green (ICG) fluorescence cholangiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jul 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- From October 2016 to May 2022, donors and their corresponding recipients underwent laparoscopic donor liver acquisition surgery in the general surgery department of Huashan Hospital.
- Donor age ≥ 18 years old, regardless of gender; The receptor is the corresponding receptor of the donor, and the age and sex of the receptor are unlimited.
- The medical history is complete, which can meet the requirements of this study.
- Volunteer to participate in this study.
Who cannot join
- The medical history is incomplete, which cannot meet the requirements of this study.
- The donor or recipient expressly refused to participate in this study.
About this study
Official title: Retrospective Study on the Application of ICG Fluorescence Cholangiography in Laparoscopic Living Donor Left Lateral Sectionectomy
The purpose of this study was to assess the effects of indocyanine green (ICG) fluorescence cholangiography during laparoscopic left lateral sectionectomy (LLLS) on the occurrence of biliary complications in both donors and recipients in living donor liver transplantation (LDLT) and to explore the optimal dose and injection time of ICG.
Read the detailed description
This was a retrospective cohort study. The purpose of this study was to assess the effects of indocyanine green (ICG) fluorescence cholangiography during LLLS on the occurrence of biliary complications in both donors and recipients. The optimal dose and injection time of ICG were also investigated. From October 2016 to May 2022, the clinical data of 85 donors who underwent LLLS and relevant recipients in the Department of General Surgery of Huashan Hospital were retrospectively analyzed. According to whether ICG fluorescence cholangiography was used, they were divided into a non-ICG group (n=46) and an ICG group (n=39). Biliary complications were observed and the optimal dose and injection time of ICG were explored.
- Conditions
- Living Donor Liver Transplantation
- Being tested
- indocyanine green (ICG) fluorescence cholangiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indocyanine green (ICG) fluorescence cholangiographyProcedure or surgery
indocyanine green (ICG) fluorescence cholangiography during operation
| Study group | Role | What they receive |
|---|---|---|
| ICG group | Experimental | indocyanine green (ICG) fluorescence cholangiography Receives: Procedure: indocyanine green (ICG) fluorescence cholangiography |
| non ICG group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biliary complications
bile leakage and biliary stenosis
Measured: two months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study startOct 2016
- Primary completionMay 2022
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living Donor Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lunxiu Qin, Fudan University
- Investigators
- Lunxiu Qin, Principal investigator, Department of general surgery, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506020
- Sponsor's protocol ID
- Huashan009
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on the Application of ICG Fluorescence Cholangiography in Laparoscopic Living Donor Left Lateral Sectionectomy
- ClinicalTrials.gov ID
- NCT05506020
- Acronym / sponsor ID
- Huashan009
- Conditions
- Living Donor Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2022 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 18 Aug 2022 (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.
The purpose of this study was to assess the effects of indocyanine green (ICG) fluorescence cholangiography during laparoscopic left lateral sectionectomy (LLLS) on the occurrence of biliary complications in both donors and recipients in living donor liver transplantation (LDLT) and to explore the optimal dose and injection time of ICG.
Detailed description
This was a retrospective cohort study. The purpose of this study was to assess the effects of indocyanine green (ICG) fluorescence cholangiography during LLLS on the occurrence of biliary complications in both donors and recipients. The optimal dose and injection time of ICG were also investigated. From October 2016 to May 2022, the clinical data of 85 donors who underwent LLLS and relevant recipients in the Department of General Surgery of Huashan Hospital were retrospectively analyzed. According to whether ICG fluorescence cholangiography was used, they were divided into a non-ICG group (n=46) and an ICG group (n=39). Biliary complications were observed and the optimal dose and injection time of ICG were explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICG group | Experimental | Procedure: indocyanine green (ICG) fluorescence cholangiographyindocyanine green (ICG) fluorescence cholangiography |
| non ICG group | No intervention | –no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- From October 2016 to May 2022, donors and their corresponding recipients underwent laparoscopic donor liver acquisition surgery in the general surgery department of Huashan Hospital.
- Donor age ≥ 18 years old, regardless of gender; The receptor is the corresponding receptor of the donor, and the age and sex of the receptor are unlimited.
- The medical history is complete, which can meet the requirements of this study.
- Volunteer to participate in this study.
Key exclusion criteria (2 listed)
- The medical history is incomplete, which cannot meet the requirements of this study.
- The donor or recipient expressly refused to participate in this study.
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 |
|---|---|---|
| indocyanine green (ICG) fluorescence cholangiographyindocyanine green (ICG) fluorescence cholangiography during operation | Procedure or surgery | ICG group |
Primary outcome
Biliary complications
Time frame: two months after operation
bile leakage and biliary stenosis
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 18 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Lunxiu Qin principal investigator
Department of general surgery, Huashan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing indocyanine green (ICG) fluorescence cholangiography in people with Living Donor Liver Transplantation, run by Fudan University.
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 4 inclusion and 2 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 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Biliary complications (time frame: two months after operation). 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 18 Aug 2022.