Consensus Conference Statement on the General use of Near-Infrared Fluorescence Imaging and Indocyanine Green Guided Surgery

Results of a Modified Delphi Study

Fernando Dip, MD; Luigi Boni, MD; Michael Bouvet, MD; Thomas Carus, MD; Michele Diana, MD; Jorge Falco, MD; Geoffrey C. Gurtner, MD; Takeaki Ishizawa, MD, PhD; Norihiro Kokudo, MD, PhD; Emanuele Lo Menzo, MD; Philip S. Low, PhD; Jaume Masia, MD; Derek Muehrcke, MD; Francis A. Papay, MD; Carlo Pulitano, MD, PhD; Sylke Schneider-Koraith, MD; Danny Sherwinter, MD; Giuseppe Spinoglio, MD; Laurents Stassen, MD, PhD; Yasuteru Urano, PhD; Alexander Vahrmeijer, MD; Eric Vibert, MD, PhD; Jason Warram, MD; Steven D. Wexner, MD, PhD (Hon); Kevin White, MD, PhD; Raul J. Rosenthal, MD

Disclosures

Annals of Surgery. 2022;275(4):685-691. 

In This Article

Abstract and Introduction

Abstract

Background: In recent decades, the use of near-infrared light and fluorescence-guidance during open and laparoscopic surgery has exponentially expanded across various clinical settings. However, tremendous variability exists in how it is performed.

Objective: In this first published survey of international experts on fluorescence-guided surgery, we sought to identify areas of consensus and nonconsensus across 4 areas of practice: fundamentals; patient selection/preparation; technical aspects; and effectiveness and safety.

Methods: A Delphi survey was conducted among 19 international experts in fluorescence-guided surgery attending a 1-day consensus meeting in Frankfurt, Germany on September 8th, 2019. Using mobile phones, experts were asked to anonymously vote over 2 rounds of voting, with 70% and 80% set as a priori thresholds for consensus and vote robustness, respectively.

Results: Experts from 5 continents reached consensus on 41 of 44 statements, including strong consensus that near-infrared fluorescence-guided surgery is both effective and safe across a broad variety of clinical settings, including the localization of critical anatomical structures like vessels, detection of tumors and sentinel nodes, assessment of tissue perfusion and anastomotic leaks, delineation of segmented organs, and localization of parathyroid glands. Although the minimum and maximum safe effective dose of ICG were felt to be 1 to 2 mg and >10 mg, respectively, there was strong consensus that determining the optimum dose, concentration, route and timing of ICG administration should be an ongoing research focus.

Conclusions: Although fluorescence imaging was almost unanimously perceived to be both effective and safe across a broad range of clinical settings, considerable further research remains necessary to optimize its use.

Introduction

Over the past few decades, with the birth and growth of minimally invasive surgical techniques that utilize advanced optoelectronic instruments, numerous different tools have been developed and tested to facilitate surgeons' visualization of essential anatomical structures in the operating room. Among these tools is near-infrared fluorescence-guided intraoperative imaging, which is currently being tested and used across an ever-expanding range of clinical settings, with the 2 goals of enhancing patient outcomes and increasing patient safety.[1–5]

Indocyanine green (ICG) is a fluorophore that responds to near-infrared irradiation (NIR), absorbing light from 790 to 805 nm and remitting it with an excitation wavelength of 835 nm.[6] Pioneering research on ICG fluorescence imaging initially emerged almost 50 years ago via the introduction of applied ophthalmic angiography.[7] Roughly 3 decades later, intraoperative fluorescent imaging made its first foray into endoscopic surgery on the liver and biliary tree.[1] Since then, the use of fluorescence imaging, and ICG in particular, has expanded exponentially.[5] This included surgery to detect tumors and sentinel lymph nodes involving the breast,[8–10] lungs,[11,12] liver,[13,14] colon,[15] stomach,[16] and pelvis[17–19] to assess tissue perfusion involving the viscera[13,20–23] and in plastic surgery, including face transplants,[24–29] to identify anastomotic leaks,[13,22,30–33] and to locate small glands such as the parathyroid glands during thyroid and parathyroid resections.[34] Despite its rapidly expanding utilization, tremendous variability exists in the dose, concentration, and administration of ICG during fluorescence-guided surgery, as well as in numerous other technical aspects of its use. Questions also persist regarding whether or not it should still be considered experimental during discussions with patients, if and when its use should be considered contraindicated, and other issues not yet addressed in clinical trials.

Our primary objectives with the present study were to assess current practices with respect to the use of fluorescence imaging, with and without ICG, and to identify areas of consensus among an international panel of surgeons who are well-recognized and published experts in the field of NIR ICG fluorescence guided surgery. For these purposes, we employed a modified Delphi survey approach to permit anonymous voting and, thereby, potentially reduce voter bias that might be caused by peer pressure. The Delphi technique and numerous variants of this technique have been gaining increasing popularity and credence as a way to achieve consensus and identify areas of nonconsensus among experts across a wide variety of health and non–health-related fields.[35]

processing....