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Annals of Surgical Oncology

Impact of Indocyanine Green Fluorescence Imaging on Lymphadenectomy Quality During Laparoscopic Distal Gastrectomy for Gastric Cancer (Greeneye): An Adaptative, Phase 2, Clinical Trial

Published in:
Authors
Carlo Sposito, MD, FEBS (HPB)
Marianna Maspero, MD
Valeria Conalbi, MD
Andrea Magarotto, MD
Michele Altomare, MD
Carlo Battiston, MD
Paolo Cantù, MD
Vincenzo Mazzaferro, MD, PhD
Published in
Annals of Surgical Oncology | Issue 11/2023

Abstract

Background

Indocyanine green (ICG)-guided lymphadenectomy using near-infrared visualization (NIR) may increase nodal yield during gastrectomy. The purpose of this study was to evaluate the clinical benefit of NIR visualization on the quality of D2 lymphadenectomy during laparoscopic distal gastrectomy.

Methods

This single-arm, open-label, Simon’s two-stage, adaptive, phase 2 trial included patients who underwent laparoscopic distal gastrectomy for gastric adenocarcinoma. Endoscopic peritumoral injection of ICG was performed 24 ± 6 h before surgery. Intraoperatively, after standard D2 lymphadenectomy and specimen extraction, NIR was used for eventual completion lymphadenectomy. The primary endpoint was clinical benefit of NIR (i.e., at least one additional harvested station containing lymph nodes, with negative points for every harvested station with no lymph nodes at final pathology).

Results

We enrolled 18 patients (61% female, median age 69 years). With NIR, an extra 23 stations were harvested: 9 contained no lymph nodes, 12 contained nonmetastatic lymph nodes, and 2 contained metastatic lymph nodes. The most commonly visualized station with NIR were station 6 (8 patients) and 1 (4 patients). The total number of harvested nodes per patient was 32 (interquartile range [IQR] 26–41), with a median of 1 (IQR 0–1) additional lymph node after NIR. Overall, seven (39%) patients had a clinical benefit from NIR, of which two (11%) had one metastatic lymph node harvested with NIR.

Conclusions

NIR visualization improves the quality of D2 lymphadenectomy in distal gastrectomy for gastric cancer. Considering the limited improve in the number of harvested lymph nodes, its real oncological benefit is still questionable.
Title
Impact of Indocyanine Green Fluorescence Imaging on Lymphadenectomy Quality During Laparoscopic Distal Gastrectomy for Gastric Cancer (Greeneye): An Adaptative, Phase 2, Clinical Trial
Authors
Carlo Sposito, MD, FEBS (HPB)
Marianna Maspero, MD
Valeria Conalbi, MD
Andrea Magarotto, MD
Michele Altomare, MD
Carlo Battiston, MD
Paolo Cantù, MD
Vincenzo Mazzaferro, MD, PhD
Publication date
13-07-2023
Publisher
Springer International Publishing
Published in
Annals of Surgical Oncology / Issue 11/2023
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-023-13848-y
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