Original Investigation
March 5, 2025
Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage: A Randomized Clinical Trial
Juha K. A. Rinne, Heikki Huhta, Tarja Pinta, et al
JAMA Surg. Published online March 5, 2025. doi:10.1001/jamasurg.2025.0006
Question Does the routine use of indocyanine green (ICG) fluorescence imaging decrease the rate of anastomotic leakages in laparoscopic colorectal surgery if low anterior resections are excluded?
Findings In this randomized clinical trial involving 1136 patients, using ICG fluorescence imaging did not reduce anastomotic leakages compared with clinical evaluation alone.
Meaning Routine use of ICG fluorescence imaging does not decrease the overall rate of anastomotic leak in laparoscopic colorectal surgery if low anterior resections are not included.
Abstract
Importance Performing a bowel anastomosis is a critical step in colorectal resection. Assessing the risk of anastomotic leakage remains challenging, even for experienced surgeons.
Objective To evaluate the use of indocyanine green (ICG) fluorescence imaging in assessing perfusion at the anastomotic site before and after anastomosis and determine whether it helps reduce anastomotic leakages.
Design, Setting, and Participants ICG-COLORAL is a prospective, randomized, multicenter study conducted from September 1, 2018, to December 31, 2023. Participants were recruited during preoperative outpatient clinic visits by clinicians not involved in the study, as well as by researchers. Participants were elective patients scheduled for laparoscopic resections, excluding low anterior resections, with planned primary anastomosis in 5 Finnish public hospitals experienced in laparoscopic colorectal surgery.
Intervention The intervention group received 5 mg of ICG intravenously before and after anastomosis formation. The fluorescence signal was assessed with a near-infrared–capable camera. The control group did not receive ICG fluorescence imaging.
Main Outcome and Measure The primary outcome measure was the anastomotic leak rate as detected by computed tomography.
Results Among 1136 patients in the intention-to-treat population, 526 (46.3%) were female and 610 (53.7%) male; they had a mean (SD) age of 70 (11) years, body mass index of 28 (5), and age-adjusted Charlson Comorbidity Index of 5 (3). Overall, the anastomotic leak rate was 5.8% (33/567) in the ICG fluorescence imaging group vs 7.9% (45/569) in the control group (odds ratio [OR], 0.73; 95% CI, 0.48-1.13; P = .16). For right-sided operations, the anastomotic leak rate with ICG fluorescence imaging was 5.9% (16/273) vs 6.7% (20/298) in the control group (OR, 0.87; 95% CI, 0.46-1.65). For left-sided operations, the anastomotic leak rate was 5.2% (14/267) with ICG fluorescence imaging vs 9.5% (23/243) without (OR, 0.55; 95% CI, 0.29-1.05). No patients reported adverse events related to ICG.
Conclusions and Relevance This study found that 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 but may be beneficial in left-sided operations.
Trial Registration ClinicalTrials.gov Identifier: NCT03602677
