Perfusion Assessment in Left-Sided/Low Anterior Resection (PILLAR III): A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes with PINPOINT Near-Infrared Fluorescence Imaging in Low Anterior Resection.

Background Indocyanine green fluoroscopy has been shown to improve anastomotic leak rates in early phase trials. Objective We hypothesized that the use of fluoroscopy to ensure anastomotic perfusion may decrease anastomotic leak following low anterior resection. Design We performed a 1:1 randomized, controlled, parallel study. Recruitment of 450-1000 patients was planned over 2-years. Setting Multicenter. Patients Patients undergoing resection defined as anastomosis within 10cm of anal verge. Intervention Patients underwent standard evaluation of tissue perfusion versus standard in conjunction with perfusion evaluation using indocyanine green fluoroscopy. Main outcome measure Primary outcome was anastomotic leak, with secondary outcomes of perfusion assessment and the rate of postoperative abscess requiring intervention. Results This study was concluded early due to decreasing accrual rates. A total of 25 centers recruited 347 patients, of which 178 were randomized to perfusion and 169 to standard. The groups had comparable tumor-specific and patient-specific demographics. Neoadjuvant chemoradiation was performed in 63.5% of perfusion and 65.7% of standard (p>0.05). Mean level of anastomosis was 5.2+3.1cm in perfusion compared to 5.2+3.3cm in standard (p>0.05). Sufficient visualization of perfusion was reported in 95.4% of patients in the perfusion group. Postoperative abscess requiring surgical management was reported in 5.7% of PFN and 4.2% of standard (p=0.75). Anastomotic leak was reported in 9.0% of perfusion compared to 9.6% of standard (p=0.37). On multivariate regression analysis, there was no difference in anastomotic leak rates between perfusion and standard (OR 0.845; 95% CI (0.375, 1.905); p=0.34). Limitations The pre-determined sample size to adequately reduce the risk of type II error was not achieved. Conclusion Successful visualization of perfusion can be achieved with ICG-F. However, no difference in anastomotic leak rates was observed between patients who underwent perfusion assessment versus standard surgical technique. In experienced hands, the addition of routine ICG-F to standard practice adds no evident clinical benefit. See Video Abstract at http://links.lww.com/DCR/B560 .