Effectiveness of Blood Perfusion Assessment by Indocyanine Green Fluorescence Angiography in the Prevention of Anastomotic Leakage after Rectal Cancer Surgery in Japan: A Retrospective Study Using the Diagnosis Procedure Combination Database.

Abstract

Background: Several studies have reported the potential effectiveness of indocyanine green fluorescence angiography (ICG-FA) for preventing anastomotic leakage (AL) in rectal cancer surgery; however, its clinical benefit remains uncertain. The purpose of this study was to investigate the effectiveness of ICG-FA in rectal cancer surgery in Japan using real-world data.

Methods: We retrieved data from the Diagnosis Procedure Combination database in Japan for rectal cancer surgeries between April 2018 and March 2022. A total of 68,022 cases were registered, and 55,299 eligible patients were analyzed. Using a two-level structure of nested individuals from 1,057 hospitals, we applied multilevel logistic regression.

Results: A total of 40,013 laparoscopic (72.4%), 7,464 robotic (13.5%), and 7,822 open (14.1%) operations were performed. The rate of AL was 4.3% in the ICG-FA group and 5.1% in the non-ICG-FA group. After adjustment for patient- and hospital-level factors, ICG-FA was associated with a lower risk of AL (OR 0.87, 95% CI 0.76-1.00, p = 0.043); however, after additional adjustment for fiscal year, the association was no longer statistically significant (OR 0.91, 95% CI 0.79-1.04, p = 0.167).

Conclusions: ICG-FA may be associated with a lower risk of AL after rectal cancer surgery in real-world settings, although the benefit was not statistically significant after additional adjustment for fiscal year.