Indocyanine green fluorescence for intraoperative detection of liver tumours in minimally invasive surgery: protocol for the LIVERGREEN phase IV multicentre clinical trial
Por:
Huerta, M, Lopez-Ben, S, Lladó, L, Sánchez-Cabús, S, Mils, K, Molina, V, Dopazo, C, Vidal, L, Dalmau, M, Caralt, M, Rosón, N, Merino, X, Armario, D, Salcedo, MT, Pellino, G, Sapisochin, G, Gómez-Gavara, C
Publicada:
16 abr 2026
Resumen:
Introduction Liver tumours are a leading cause of global morbidity and mortality. Current diagnostic tools, including computed tomography (CT), magnetic resonance imaging (MRI) and intraoperative ultrasound (IOUS), have limitations in detecting liver neoplasms. Indocyanine green (ICG) has emerged as a promising tool for improving liver tumour detection. This study aims to assess the impact of preoperative ICG on intraoperative tumour detection in minimally invasive surgery and develop a machine-learning algorithm to enhance tumour detection using ICG fluorescence.Methods and analysis This prospective, multicentre, phase IV clinical trial adheres to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Patients with liver tumours eligible for minimally invasive surgery and a preoperative imaging test will be included. ICG will be administered intravenously 24 hours before surgery. Intraoperative procedures will include IOUS, ICG mapping and photographic documentation. Patients will be followed for 90 days to assess tumour progression, morbidity and mortality. The photographic analysis will enable the development of an artificial intelligence algorithm using machine learning and neural networks to identify lesions based on ICG fluorescence. The estimated sample size is 173 patients and the trial is predicted to accrue in 3 years.Ethics and dissemination The trial will be conducted in accordance with the Declaration of Helsinki and the Spanish Agency of Medicines and Medical Devices (AEMPS) guidelines. Approved by the local institutional Ethics Committee and the AEMPS, the results will be shared with the scientific community through publications and conferences.EudraCT number 2023-5 08 316-27-00.Trial registration number NCT06398028.Protocol version V.12, 18 March 2025
Filiaciones:
Huerta, M:
Vall Hebron Univ Hosp, Dept Gen & Digest Surg, HPB Surg & Liver Transplant Unit, Barcelona, Spain
Univ Autonoma Barcelona, Barcelona, Spain
Lopez-Ben, S:
Hosp Univ Girona Doctor Josep Trueta, HPB Surg Unit, Girona, Spain
Lladó, L:
Bellvitge Univ Hosp, HPB Surg & Liver Transplant Unit, Lhospitalet De Llobregat, Spain
Univ Barcelona, Barcelona, Spain
Sánchez-Cabús, S:
Univ Autonoma Barcelona, Barcelona, Spain
Hosp Santa Creu & Sant Pau, HPB Surg Unit, Barcelona, Spain
Mils, K:
Bellvitge Univ Hosp, HPB Surg & Liver Transplant Unit, Lhospitalet De Llobregat, Spain
Univ Barcelona, Barcelona, Spain
Molina, V:
Univ Autonoma Barcelona, Barcelona, Spain
Hosp Santa Creu & Sant Pau, HPB Surg Unit, Barcelona, Spain
Dopazo, C:
Vall Hebron Univ Hosp, Dept Gen & Digest Surg, HPB Surg & Liver Transplant Unit, Barcelona, Spain
Univ Autonoma Barcelona, Barcelona, Spain
Vidal, L:
Vall Hebron Univ Hosp, Dept Gen & Digest Surg, HPB Surg & Liver Transplant Unit, Barcelona, Spain
Univ Autonoma Barcelona, Barcelona, Spain
Dalmau, M:
Vall Hebron Univ Hosp, Dept Gen & Digest Surg, HPB Surg & Liver Transplant Unit, Barcelona, Spain
Univ Autonoma Barcelona, Barcelona, Spain
Caralt, M:
Vall Hebron Univ Hosp, Dept Gen & Digest Surg, HPB Surg & Liver Transplant Unit, Barcelona, Spain
Univ Autonoma Barcelona, Barcelona, Spain
Rosón, N:
Univ Autonoma Barcelona, Barcelona, Spain
Vall Hebron Univ Hosp, Dept Radiol, Barcelona, Spain
Merino, X:
Univ Autonoma Barcelona, Barcelona, Spain
Vall Hebron Univ Hosp, Dept Radiol, Barcelona, Spain
Armario, D:
Univ Autonoma Barcelona, Barcelona, Spain
Vall Hebron Univ Hosp, Dept Radiol, Barcelona, Spain
Salcedo, MT:
Univ Autonoma Barcelona, Barcelona, Spain
Vall Hebron Univ Hosp, Dept Pathol, Barcelona, Spain
Pellino, G:
Univ Autonoma Barcelona, Barcelona, Spain
Vall Hebron Univ Hosp, Dept Gen & Digest Surg, Colorectal Surg Unit, Barcelona, Spain
Sapisochin, G:
Vall Hebron Univ Hosp, Dept Gen & Digest Surg, HPB Surg & Liver Transplant Unit, Barcelona, Spain
Univ Autonoma Barcelona, Barcelona, Spain
Gómez-Gavara, C:
Vall Hebron Univ Hosp, Dept Gen & Digest Surg, HPB Surg & Liver Transplant Unit, Barcelona, Spain
Univ Autonoma Barcelona, Barcelona, Spain
Green Submitted, gold
|