Evidence map›Paper›PMID 35914905›Full record

ArticleBMJ open2022

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.

Alessandro Coppola, Giuseppe Bianco, Quirino Lai, Giuseppe Marrone, Miriam Caimano, Salvatore Agnes, Gabriele Spoletini

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05228587 (Indocyanine Green Clearance Test in Liver Transplantation), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05228587 naunknown statusnot on this map

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

TypeinterventionalSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCSRan2022 to 2024Enrolled162ConditionsHepatic and Hepatobiliary DisordersArmsIndocyanine green
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 2 countries.

Alessandro CoppolaGeneral and Liver Transplant Surgery, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.
Giuseppe BiancoGeneral and Liver Transplant Surgery, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy giuseppe.bianco@policlinicogemelli.it.ORCID 0000-0001-7451-4002
Quirino LaiHepatobiliary and Liver Transplant Surgery, Umberto I Policlinico di Roma, Roma, Italy.
Giuseppe MarroneGeneral and Liver Transplant Surgery, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.
Miriam CaimanoGeneral and Liver Transplant Surgery, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.
Salvatore AgnesGeneral and Liver Transplant Surgery, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.
Gabriele SpoletiniGeneral and Liver Transplant Surgery, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.ORCID 0000-0002-6855-4515
Agostino Gemelli University Polyclinic · ITSecond Military Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionViability assessment of the graft is essential to lower the risk of liver transplantation (LT) failure and need for emergency retransplantation, 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.This study aims to trial the use of indocyanine green clearance test (IGT) in the donor as an objective tool to assess graft viability and in the recipient to assess graft function recovery after LT. METHODS AND ANALYSIS: This is an observational prospective single-centre study on consecutive liver transplant donors and recipients. PRIMARY

objectiveTo determine the capability of IGT of predicting graft viability at the time of organ retrieval. Indocyanine green will be administered to the donor and the plasma disappearance rate (PDR) measured using the pulsidensitometric method. Some 162 IGT donor procedures will be required (α, 5%; β, 20%) using an IGT-PDR cut-off value of 13% to achieve a significant discrimination between viable and non-viable grafts. SECONDARY

objectiveIGT-PDR will be measured at different time-points in the LT recipient: during the anhepatic phase, after graft reperfusion, at 24 hours, on day 3 and day 7 after LT. The slope of IGT values from the donor to the recipient will be evaluated for correlation with the development of early allograft dysfunction. ETHICS AND DISSEMINATION: This research protocol was approved by Fondazione Policlinico Universitario Agostino Gemelli IRCCS Ethics Committee (reference number: 0048466/20, study ID: 3656) and by the Italian National Transplant Center (CNT) (reference number: Prot.11/CNT2021). Liver recipients will be required to provide written informed consent. Results will be published in international peer-reviewed scientific journals and presented in congresses. TRIAL REGISTRATION NUMBER: NCT05228587.

Indexed as

Liver TransplantationGraft SurvivalHumansIndocyanine GreenLiverObservational Studies as TopicProspective StudiesRecovery of FunctionTissue and Organ HarvestingIndocyanine GreenHepatobiliary surgeryHepatologyTransplant surgery

Identifiers

PMID35914905
PMCPMC9345038
OpenAlexW4289643367

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.