Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Minami-ku, Yokohama, Japan.
Department of Surgery, Surgical Oncology and Science, Sapporo Medical University, Chuo-ku, Sapporo, Japan.
Ann Surg. 2023 Oct 1;278(4):e688-e694. doi: 10.1097/SLA.0000000000005907. Epub 2023 May 23.
The aim of the present randomized controlled trial was to evaluate the superiority of indocyanine green fluorescence imaging (ICG-FI) in reducing the rate of anastomotic leakage in minimally invasive rectal cancer surgery.
The role of ICG-FI in anastomotic leakage in minimally invasive rectal cancer surgery is controversial according to the published literature.
This randomized, open-label, phase 3, trial was performed at 41 hospitals in Japan. Patients with clinically stage 0-III rectal carcinoma less than 12 cm from the anal verge, scheduled for minimally invasive sphincter-preserving surgery were preoperatively randomly assigned to receive a blood flow evaluation by ICG-FI (ICG+ group) or no blood flow evaluation by ICG-FI (ICG- group). The primary endpoint was the anastomotic leakage rate (grade A+B+C, expected reduction rate of 6%) analyzed in the modified intention-to-treat population.
Between December 2018 and February 2021, a total of 850 patients were enrolled and randomized. After the exclusion of 11 patients, 839 were subject to the modified intention-to-treat population (422 in the ICG+ group and 417 in the ICG- group). The rate of anastomotic leakage (grade A+B+C) was significantly lower in the ICG+ group (7.6%) than in the ICG- group (11.8%) (relative risk, 0.645; 95% confidence interval 0.422-0.987; P =0.041). The rate of anastomotic leakage (grade B+C) was 4.7% in the ICG+ group and 8.2% in the ICG- group ( P =0.044), and the respective reoperation rates were 0.5% and 2.4% ( P =0.021).
Although the actual reduction rate of anastomotic leakage in the ICG+ group was lower than the expected reduction rate and ICG-FI was not superior to white light, ICG-FI significantly reduced the anastomotic leakage rate by 4.2%.
本随机对照试验的目的是评估吲哚菁绿荧光成像（ICG-FI）在降低微创直肠癌手术吻合口漏发生率方面的优势。
根据已发表的文献，ICG-FI 在微创直肠癌手术吻合口漏中的作用存在争议。
这项在日本 41 家医院进行的随机、开放标签、3 期临床试验，纳入了临床分期为 0-III 期、距肛缘小于 12cm 的直肠腺癌患者，这些患者拟行微创保肛手术，术前随机分为接受吲哚菁绿荧光血流评估（ICG+ 组）或不接受吲哚菁绿荧光血流评估（ICG- 组）。主要终点是改良意向治疗人群中的吻合口漏发生率（A级+B级+C 级，预期降低率 6%）。
在 2018 年 12 月至 2021 年 2 月期间，共纳入 850 例患者并进行随机分组。排除 11 例患者后，839 例患者进入改良意向治疗人群（ICG+ 组 422 例，ICG- 组 417 例）。ICG+ 组的吻合口漏（A级+B 级+C 级）发生率明显低于 ICG- 组（7.6%比 11.8%）（相对风险，0.645；95%置信区间，0.422-0.987；P=0.041）。ICG+ 组的吻合口漏（B 级+C 级）发生率为 4.7%，ICG- 组为 8.2%（P=0.044），相应的再次手术率分别为 0.5%和 2.4%（P=0.021）。
尽管 ICG+ 组的实际吻合口漏降低率低于预期降低率，并且 ICG-FI 并不优于白光，但 ICG-FI 确实显著降低了 4.2%的吻合口漏发生率。
