A randomized clinical trial assessed the impact of indocyanine green fluorescence imaging on anastomotic leak rates in laparoscopic colorectal surgery.
The study, published in JAMA Surgery, was conducted across five Finnish hospitals from 2018 to 2023. Investigators recruited 1,136 patients undergoing elective colorectal resections with primary anastomosis, excluding low anterior resections.
The investigators found no statistically significant reduction in overall anastomotic leaks with indocyanine green (ICG) fluorescence imaging (5.8% vs 7.9%, odds ratio [OR] = 0.73, 95% confidence interval [CI] = 0.48–1.13, P = .16). However, a potential benefit emerged for left-sided colorectal resections, where leak rates were 5.2% with ICG vs. 9.5% without (OR = 0.55, 95% CI = 0.29–1.05). Right-sided surgeries showed no meaningful difference (5.9% vs. 6.7%, OR = 0.87, 95% CI = 0.46–1.65).
Patients were randomized to standard clinical assessment or additional ICG fluorescence imaging. The patients in the intervention group received a 5 mg intravenous dose of ICG prior to and following anastomosis formation, with fluorescence assessed using near-infrared–capable cameras. The study population had a mean age of 70 years, mean body mass index of 28, and an age-adjusted Charlson Comorbidity Index of 5. No ICG-related adverse events were reported.
Secondary outcomes showed a higher rate of anastomotic site adjustments in the ICG group (7.2% vs 4.4%, P = .048), but no statistically significant differences in reoperation rates (9.7% vs 10.0%) or hospital stays (mean = 5.6 days for both groups). Despite being powered to detect a significant reduction in leaks, the study did not achieve statistical significance.
While previous meta-analyses suggest ICG could reduce anastomotic leaks—especially in low anterior resections—the new trial highlighted limitations, including subjective fluorescence assessments, camera positioning variations, and a learning curve among surgeons. Missing data and protocol deviations also impacted the final analysis.
"Routine use of ICG fluorescence imaging does not significantly reduce the overall anastomotic leak rate in laparoscopic colorectal surgery if low anterior resections are excluded," said lead study author Juha K. A. Rinne, MD, of the Department of Surgery at the Päijät-Häme Central Hospital in Lahti, Finland, and colleagues. "Routine use of ICG fluorescence imaging in laparoscopic colon surgery does not appear to be warranted," they added.
As one of the largest randomized trials on ICG fluorescence imaging in colorectal surgery, the findings suggested its routine use may not be justified but could provide select benefits in left-sided colorectal procedures. Further research is needed to clarify its role in surgical decision-making.
The authors reported no conflicts of interest.