Ichkhanian, Y., Vosoughi, K., Diehl, D. L., Grimm, I. S., James, T. W., Templeton, A. W., Hajifathalian, K., Tokar, J. L., Samarasena, J. B., Chehade, N. El Hage, Lee, J., Chang, K., Mizrahi, M., Barawi, M., Irani, S., Friedland, S., Korc, P., Aadam, A. A., Al-Haddad, M. A., Kowalski, T. E., Novikov, A., Smallfield, G., Ginsberg, G. G., Oza, V. M., Panuu, D., Fukami, N., Pohl, H., Lajin, Michael, Kumta, N. A., Tang, S. J., Naga, Y. M., Amateau, S. K., Brewer, G. O. I., Kumbhari, V., Sharaiha, R., and Khashab, Mouen A.
Background: Introduction of the full-thickness resection device (FTRD) has allowed endoscopic resection of difficult lesions such as those with deep wall origin/infiltration or those located in difficult anatomic locations. The aim of this study is to assess the outcomes of the FTRD among its early users in the USA. Methods: Patients who underwent endoscopic full-thickness resection (EFTR) for lower gastrointestinal tract lesions using the FTRD at 26 US tertiary care centers between 10/2017 and 12/2018 were included. Primary outcome was R0 resection rate. Secondary outcomes included rate of technical success (en bloc resection), achievement of histologic full-thickness resection (FTR), and adverse events (AE). Results: A total of 95 patients (mean age 65.5?±?12.6 year, 38.9% F) were included. The most common indication, for use of FTRD, was resection of difficult adenomas (non-lifting, recurrent, residual, or involving appendiceal orifice/diverticular opening) (66.3%), followed by adenocarcinomas (22.1%), and subepithelial tumors (SET) (11.6%). Lesions were located in the proximal colon (61.1%), distal colon (18.9%), or rectum (20%). Mean lesion diameter was 15.5?±?6.4 mm and 61.1% had a prior resection attempt. The mean total procedure time was 59.7?±?31.8 min. R0 resection was achieved in 82.7% while technical success was achieved in 84.2%. Histologically FTR was demonstrated in 88.1% of patients. There were five clinical AE (5.3%) with 2 (2.1%) requiring surgical intervention. Conclusions: Results from this first US multicenter study suggest that EFTR with the FTRD is a technically feasible, safe, and effective technique for resecting difficult colonic lesions.