Clinical trial · Interventional
Indocyanine Green Clearance Test in Liver Transplantation (LivInG)
Indocyanine Green Clearance Test in Liver Transplantation: Defining Cut-off Levels for Graft Viability Assessment During Organ Retrieval and for the Prediction of Post-transplant Graft Function Recovery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The gap between patients awaiting and those undergoing liver transplantation (LT) continues to grow. Marginal organs carry higher risk of failure after LT however they are increasingly used to fill such gap. Viability assessment of the graft is essential to lower the risk of LT failure and need for emergency re-LT, however this still relies mainly on surgeon's experience. Post-LT graft function recovery assessment is also essential to aid physicians in the management of LT recipients and guide them through challenging decision-making. With the present study we aim to validate the use of indocyanine green clearance test (IGT) in two settings: in the donor as an objective tool to assess graft viability; in the recipient to assess graft function recovery after LT. The implementation of IGT in routine practice translates into two main advantages: to avoid using grafts with no chance of recovery and to optimize resource allocation to LT recipients depending on their graft function recovery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic and Hepatobiliary Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Liver Transplants
- description
- Indocyanine Green will be injected in liver donors for measuring plasma disappearance rate with a non invasive measurement device. Liver recipients will receive indocyanine green injection for measuring plasma disappearance rate at different time-points.
- interventionNames
- Drug: Indocyanine green
Primary outcomes (1)
- measure
- To identify IGT PDR cut-off level below which the liver graft is not to be used for solid organ transplantation
- timeFrame
- During organ donor retrieval surgery
- description
- Organ donors will be managed according to the Italian National Transplant Center (CNT) policy and the current study will not require any change to standard practice. Indocyanine green 20 ml will be administered to the multiorgan donor upon arrival in the operating room by a researcher of this study. The IGT plasma disappearance rate will be measured using the pulsidensitometric method (LiMON System, Impulse Medical System, Munich, Germany - or alternative/equivalent device) by the same researcher, recorded and secured inside a specially designed "IGT Study Box". The value obtained will not be revealed to the surgical retrieval team who will carry out the operation without any deviation from standard practice because of the current study (i.e. surgical team blinded).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All consecutive liver donors included in the study period * All consecutive liver recipients transplanted in the study period from a donor tested with Indocyanine Green Exclusion Criteria: * Donor or recipients history of allergy to hyodine.
References
Publications (10)
- BACKGROUNDLo IJ, Lefkowitch JH, Feirt N, Alkofer B, Kin C, Samstein B, Guarrera JV, Renz JF. Utility of liver allograft biopsy obtained at procurement. Liver Transpl. 2008 May;14(5):639-46. doi: 10.1002/lt.21419. PMID 18324657
- BACKGROUNDLevesque E, Martin E, Dudau D, Lim C, Dhonneur G, Azoulay D. Current use and perspective of indocyanine green clearance in liver diseases. Anaesth Crit Care Pain Med. 2016 Feb;35(1):49-57. doi: 10.1016/j.accpm.2015.06.006. Epub 2015 Oct 21. PMID 26477363
- BACKGROUNDLau H, Man K, Fan ST, Yu WC, Lo CM, Wong J. Evaluation of preoperative hepatic function in patients with hepatocellular carcinoma undergoing hepatectomy. Br J Surg. 1997 Sep;84(9):1255-9. PMID 9313707
- BACKGROUNDWang W, Zhao Q, Hu A, He X, Zhu X. Application of Indocyanine Green (ICG) Detection in Evaluating Early Prognosis in Patients with Fatty Liver Disease After Liver Transplantation. Ann Transplant. 2017 Apr 11;22:208-214. doi: 10.12659/aot.901277. PMID 28396579
- BACKGROUNDTang Y, Han M, Chen M, Wang X, Ji F, Zhao Q, Zhang Z, Ju W, Wang D, Guo Z, He X. Donor Indocyanine Green Clearance Test Predicts Graft Quality and Early Graft Prognosis After Liver Transplantation. Dig Dis Sci. 2017 Nov;62(11):3212-3220. doi: 10.1007/s10620-017-4765-x. Epub 2017 Sep 20. PMID 28932926
- BACKGROUNDLevesque E, Saliba F, Benhamida S, Ichai P, Azoulay D, Adam R, Castaing D, Samuel D. Plasma disappearance rate of indocyanine green: a tool to evaluate early graft outcome after liver transplantation. Liver Transpl. 2009 Oct;15(10):1358-64. doi: 10.1002/lt.21805. PMID 19790157
- BACKGROUNDSchneider L, Spiegel M, Latanowicz S, Weigand MA, Schmidt J, Werner J, Stremmel W, Eisenbach C. Noninvasive indocyanine green plasma disappearance rate predicts early complications, graft failure or death after liver transplantation. Hepatobiliary Pancreat Dis Int. 2011 Aug;10(4):362-8. doi: 10.1016/s1499-3872(11)60061-1.