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

Abstract

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 after low anterior resection. DESIGN:We performed a 1:1 randomized controlled parallel study. Recruitment of 450 to 1000 patients was planned over 2 years. SETTINGS:This was a multicenter trial.

Safety and Efficacy of Indocyanine Green in Colorectal Cancer Surgery: A Systematic Review and Meta-Analysis of 11,047 Patients

“…Two of these support the hypothesis of the positive role of ICG fluorescein angiography in decreasing rates of anastomotic insufficiency, while one of them, despite the authors’ previous findings in a former phase II study, failed to demonstrate any difference between the outcomes in the examined groups. Our sub-analysis encompassing randomized clinical trials [ 18 , 24 , 31 ] showed an anastomotic leak rate of 8.1% in the ICG group and 12.1% in the non-ICG group (RR = 0.67; 95% CI: 0.46–0.98; p = 0.04).…”

“…A total of 1936 references were finally confirmed by the electronic search, and 73 potentially relevant studies were selected after screening the titles and abstracts. Among the 73 potentially relevant studies, a total of 32 met the inclusion criteria [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 ]. Table 1 and Table S1 summarize the study characteristics.…”

“…The sub-analysis performed with respect to the type of study design showed an anastomotic leak rate of 8.1% in the ICG group compared with 12.1% in the non-ICG group (RR = 0.67; 95% CI: 0.46–0.98; p = 0.04) for RCTs [ 18 , 24 , 31 ] and a rate of 3.1% vs. 7.3%, respectively (RR = 0.43; 95% CI: 0.35–0.52; p < 0.001) for non-RCTs.…”

“…The following supporting information can be downloaded at: . Table S1: Methodology characteristics of the included trials [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 ]; Table S2: Pooled analysis in subgroups of randomized and non-randomized trials; Table S3: PRISMA checklist. Figure S1: A summary table of the review authors’ judgements for each risk of bias item for each randomized study; Figure S2: A plot of the distribution of the review authors’ judgements for each risk of bias item across randomized studies; Figure S3: A summary table of the review authors’ judgements for each risk of bias item for each non-randomized study; Figure S4: A plot of the distribution of the review authors’ judgements for each risk of bias item across non-randomized studies.…”

Effect of Indocyanine Green Fluorescence Angiography on Anastomotic Leakage in Patients Undergoing Colorectal Surgery: A Meta-Analysis of Randomized Controlled Trials and Propensity-Score-Matched Studies

“…However, baseline data from most cohort studies (15)(16)(17)(18)(19) do not match, which has stimulated the interest of investigators in conducting high-quality randomized controlled trials (RCTs) to investigate the effect of ICG on AL prevention. Two large and highly anticipated RCTs (20,21) published recently have shown that ICG fluorescein angiography does not reduce the incidence of postoperative AL, nor does it reduce postoperative complications or mortality. Existing metaanalyses include either low-quality evidence or a limited number of RCTs, so the results of these meta-analyses (4,5,8,22,23) are not convincing.…”