The iGreenGO Study: The Clinical Role of Indocyanine Green Imaging Fluorescence in Modifying the Surgeon's Conduct During the Surgical Treatment of Advanced Gastric Cancer-Study Protocol for an International Multicenter Prospective Study.

D2 lymphadenectomy advanced gastric cancer indocyanine green (ICG) surgery surgical conduct

Journal

Frontiers in oncology
ISSN: 2234-943X
Titre abrégé: Front Oncol
Pays: Switzerland
ID NLM: 101568867

Informations de publication

Date de publication:
2022
Historique:
received: 14 01 2022
accepted: 14 02 2022
entrez: 4 4 2022
pubmed: 5 4 2022
medline: 5 4 2022
Statut: epublish

Résumé

The near-infrared/indocyanine green imaging fluorescence (NIR/ICG) technology is showing promising results in several fields of surgical oncology. The clinical value of NIR/ICG technology in the surgical treatment of advanced gastric cancer (AGC) is not clearly established. This is the protocol of the "iGreenGO" (indocyanine Green Gastric Observation) Study, a national prospective multicenter study. Western patients who undergo curative-intent gastrectomy with D2 lymphadenectomy for AGC constitute the study cohort. All the patients undergo preoperative upper gastrointestinal endoscopy for submucosal peritumoral ICG injection at the most 20 h before surgery. Intraoperative endoscopic injection before starting surgical dissection is also allowed. The primary endpoint is the "change in the surgical conduct" (CSC), i.e., the need to perform further dissection after intraoperative NIR/ICG technology activation at the end of D2 lymphadenectomy. Secondary endpoints include the pattern of abdominal fluorescence distribution according to tumor and patient characteristics, the preoperative clinical variables potentially associated with CSC, and the incidence of stage migration due to NIR/ICG application. The iGreenGO Study is the first study to investigate the clinical role of NIR/ICG technology for the surgical treatment of AGC in a large cohort of Western patients. Results from the present study can further clarify the role of NIR/ICG technology in surgical lymphadenectomy for AGC.

Sections du résumé

Background UNASSIGNED
The near-infrared/indocyanine green imaging fluorescence (NIR/ICG) technology is showing promising results in several fields of surgical oncology. The clinical value of NIR/ICG technology in the surgical treatment of advanced gastric cancer (AGC) is not clearly established.
Methods UNASSIGNED
This is the protocol of the "iGreenGO" (indocyanine Green Gastric Observation) Study, a national prospective multicenter study. Western patients who undergo curative-intent gastrectomy with D2 lymphadenectomy for AGC constitute the study cohort. All the patients undergo preoperative upper gastrointestinal endoscopy for submucosal peritumoral ICG injection at the most 20 h before surgery. Intraoperative endoscopic injection before starting surgical dissection is also allowed. The primary endpoint is the "change in the surgical conduct" (CSC), i.e., the need to perform further dissection after intraoperative NIR/ICG technology activation at the end of D2 lymphadenectomy. Secondary endpoints include the pattern of abdominal fluorescence distribution according to tumor and patient characteristics, the preoperative clinical variables potentially associated with CSC, and the incidence of stage migration due to NIR/ICG application.
Discussion UNASSIGNED
The iGreenGO Study is the first study to investigate the clinical role of NIR/ICG technology for the surgical treatment of AGC in a large cohort of Western patients. Results from the present study can further clarify the role of NIR/ICG technology in surgical lymphadenectomy for AGC.

Identifiants

pubmed: 35372091
doi: 10.3389/fonc.2022.854754
pmc: PMC8968043
doi:

Types de publication

Journal Article

Langues

eng

Pagination

854754

Informations de copyright

Copyright © 2022 Lombardi, Mazzola, Nicastro, Giacopuzzi, Baiocchi, Castoro, Rosati, Fumagalli Romario, Bonavina, Staderini, Gockel, Gregori, De Martini, Gualtierotti, Danieli, Beretta, Mutignani, Forti and Ferrari.

Déclaration de conflit d'intérêts

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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Auteurs

Pietro Maria Lombardi (PM)

Unit of Foregut Surgery, IRCCS Humanitas Research Hospital, Milan, Italy.

Michele Mazzola (M)

Division of Minimally-Invasive Surgical Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.

Vincenzo Nicastro (V)

Division of Minimally-Invasive Surgical Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.

Simone Giacopuzzi (S)

General and Upper GI Surgery Division, University of Verona, Verona, Italy.

Gian Luca Baiocchi (GL)

General Surgery, ASST Cremona, Cremona, Italy.
Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.

Carlo Castoro (C)

Unit of Foregut Surgery, IRCCS Humanitas Research Hospital, Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Milan, Italy.

Riccardo Rosati (R)

Department of Gastrointestinal Surgery, San Raffaele Hospital IRCCS, Faculty of Medicine and Surgery, Vita-Salute San Raffaele University, Milan, Italy.

Uberto Fumagalli Romario (U)

Department of Digestive Surgery, Istituto Europeo di Oncologia IRCCS, Milan, Italy.

Luigi Bonavina (L)

Division of General and Foregut Surgery, Department of Biomedical Sciences for Health, Policlinico San Donato, University of Milan, Milan, Italy.

Fabio Staderini (F)

Digestive Surgery Unit, Department of Clinical and Experimental Medicine, Careggi University Hospital of Florence, Florence, Italy.

Ines Gockel (I)

Department of Visceral, Transplantation, Thoracic and Vascular Surgery, University Hospital Leipzig, Leipzig, Germany.

Dario Gregori (D)

Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac Thoracic Vascular Sciences and Public Health, University of Padova, Padova, Italy.

Paolo De Martini (P)

Division of Minimally-Invasive Surgical Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.

Monica Gualtierotti (M)

Division of Minimally-Invasive Surgical Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.

Maria Danieli (M)

Division of Minimally-Invasive Surgical Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.

Simona Beretta (S)

Data Management Unit, Division of Minimally-Invasive Surgical Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.

Massimiliano Mutignani (M)

Department of Digestive Endoscopy, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.

Edoardo Forti (E)

Department of Digestive Endoscopy, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.

Giovanni Ferrari (G)

Division of Minimally-Invasive Surgical Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.

Classifications MeSH