Trial reportSurgical endoscopy2026
Quantitative assessment of gastric tube perfusion during Ivor Lewis esophagectomy using indocyanine-green: results from the prospective interventional trial SPY Q-ICG PAS study.
Trial report in Surgical endoscopy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05489757 (SPY Portable Handheld Imaging), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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SPY Portable Handheld Imaging (SPY-PHI) System With SPY-QP Software for Quantitative Fluorescence Angiography With IndoCyanine Green for Perfusion Assessment During Surgery
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10 authors.
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Abstract
backgroundIndocyanine green (ICG) fluorescence angiography is increasingly used to assess the vascularization of abdominal organs. In recent years, there has been a growing need to move beyond the subjectivity associated with its qualitative assessment by introducing objective quantification parameters (Q-ICG). The aim of this study is to identify a potential correlation between Q-ICG parameters and the risk of anastomotic leakage (AL) following Ivor Lewis esophagectomy for cancer.
methodsThe SPY Q-ICG PAS study (NCT05489757) is a single-center, prospective, interventional trial conducted at San Raffaele Hospital in Milan between 2022 and 2023. In all patients undergoing Ivor Lewis esophagectomy for cancer, the following Q-ICG parameters were evaluated at the end of gastric conduit creation: maximum intensity (Fmax), half of Fmax intensity (F1), plateau intensity, intensity at the future anastomosis site, the time to reach F1 intensity (T1), the time to reach Fmax (time-to-peak, TTP), the ratio of TTP and T1 (TR), and Slope (Fmax/TTP).
resultsOverall, 7 out of 76 patients (9.2%) experienced AL. No statistically significant differences were found between the AL and no-AL groups in terms of perioperative variables. Considering the Q-ICG parameters, the AL group exhibited longer T1 (17 ± 10 vs. 7 ± 2 s; p < 0,001), higher TR (0.71 ± 0.09 vs. 0.40 ± 0.10; p < 0,001), and lower Slope (3.94 ± 1.98 vs. 6.26 ± 2.79; p = 0.04). After multivariate analysis, T1 remained the only independent predictive factor for AL (OR = 5.613; p = 0.044). Moreover, a T1 of 9.50 s was identified as the best cut-off able to correctly classify patients in terms of AL in 89% of cases, with a sensitivity of 100% and a specificity of 88% (p < 0.001).
conclusionsAmong all Q-ICG parameters, T1 resulted the best indicator for identifying patients at higher risk of developing postoperative AL following Ivor Lewis esophagectomy.
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