Indocyanine Green Clearance Test in Liver Transplantation (LivInG)

NCT05228587 | Unknown DMC

• 1 other identifier: 3656
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hepatic and Hepatobiliary Disorders

Keywords

Organ donation; Indocyanine Green Clearance; Liver injury, repair; Liver ischemia-reperfusion injury; Liver dysplasia and pre-neoplasia; Liver Transplant

Outcome Measures

Primary Outcomes (1)

• To identify IGT PDR cut-off level below which the liver graft is not to be used for solid organ transplantation

  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).

  During organ donor retrieval surgery

Secondary Outcomes (1)

• To identify IGT PDR cut-off level(s) below which post-LT organ recovery is impaired (early allograft dysfunction).

  From Transplant to the 7th postoperative day

Study Arms (1)

Liver Transplants

EXPERIMENTAL

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.

Drug: Indocyanine green

Interventions

Indocyanine green DRUG

Indocyanine green will be injected in all donor

Also known as: Injection of Indocyanine green

Liver Transplants

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Donor or recipients history of allergy to hyodine.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Azienda Policlinico Umberto I: collaborator

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Related Publications (10)

• Lo 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 BACKGROUND

• Levesque 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 BACKGROUND

• Lau 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 BACKGROUND

• Wang 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 BACKGROUND

• Tang 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 BACKGROUND

• Levesque 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 BACKGROUND

• Schneider 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.

  PMID: 21813383 BACKGROUND

• Imamura H, Sano K, Sugawara Y, Kokudo N, Makuuchi M. Assessment of hepatic reserve for indication of hepatic resection: decision tree incorporating indocyanine green test. J Hepatobiliary Pancreat Surg. 2005;12(1):16-22. doi: 10.1007/s00534-004-0965-9.

  PMID: 15754094 BACKGROUND

• Olthoff KM, Kulik L, Samstein B, Kaminski M, Abecassis M, Emond J, Shaked A, Christie JD. Validation of a current definition of early allograft dysfunction in liver transplant recipients and analysis of risk factors. Liver Transpl. 2010 Aug;16(8):943-9. doi: 10.1002/lt.22091.

  PMID: 20677285 BACKGROUND

• Coppola A, Bianco G, Lai Q, Marrone G, Caimano M, Agnes S, Spoletini G. 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 - the Liver Indocyanine Green (LivInG) Trial Study Protocol. BMJ Open. 2022 Aug 1;12(8):e063081. doi: 10.1136/bmjopen-2022-063081.

  PMID: 35914905 DERIVED

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Gabriele Spoletini, MD, PhD

CONTACT

00390630154955; gabriele.spoletini@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 8, 2022
• Study Start: February 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: March 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)