ICG-COLORAL
Trial question
What is the role of indocyanine green fluorescence imaging for anastomotic leaks in patients undergoing laparoscopic colorectal resection?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 1136
1136 patients (526 female, 610 male).
Inclusion criteria: adult patients undergoing elective laparoscopic colorectal resection with planned primary anastomosis.
Key exclusion criteria: planned anastomosis below the peritoneal fold; IBD; planned end ostomy; planned diverting stoma; planned laparotomy; active abscess or enteric fistula; previous serious adverse events related to IV iodine use.
Interventions
N=567 indocyanine green fluorescence imaging (5 mg of IV indocyanine green given before and after anastomosis formation with fluorescence signal assessed).
N=569 usual care (clinical evaluation only without the receipt of indocyanine green fluorescence imaging).
Primary outcome
Anastomotic leak rate as detected by computed tomography
5.8%
7.9%
7.9 %
5.9 %
4.0 %
2.0 %
0.0 %
Indocyanine green fluorescence
imaging
Usual
care
No significant
difference ↔
No significant difference in anastomotic leak rate as detected by CT (5.8% vs. 7.9%; OR 0.73, 95% CI 0.48 to 1.13).
Secondary outcomes
No significant difference in overall reoperations (9.5% vs. 9.9%; ARD -0.4, 95% CI -4.27 to 3.47).
No significant difference in anastomotic leak rate, right-sided operations (5.9% vs. 6.7%; OR 0.87, 95% CI 0.46 to 1.65).
No significant difference in anastomotic leak rate, left-sided operations (5.2% vs. 9.5%; OR 0.55, 95% CI 0.29 to 1.05).
Conclusion
In adult patients undergoing elective laparoscopic colorectal resection with planned primary anastomosis, indocyanine green fluorescence imaging was not superior to usual care with respect to anastomotic leak rate as detected by CT.
Reference
Juha K A Rinne, Heikki Huhta, Tarja Pinta et al. Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage: A Randomized Clinical Trial. JAMA Surg. 2025 Mar 5:e250006. Online ahead of print.
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