Jafari, M.D., Pigazzi, A., McLemore, E.C., Mutch, M.G., Haas, E., Rasheid, S., Wait, A.D., Paquette, I.M., Bardakcioglu, O., Safar, B., Landmann, R.G., Varma, M., Maron, D.J., Martz, J., Bauer, J., George, V.V., Fleshman, J.W., Steele, S.R. and Stamos, M.J. (2021). “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.” Dis Colon Rectum.
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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