Adverse events of endoscopic full-thickness resection: results from the German and Dutch nationwide colorectal FTRD registry
Liselotte W. Zwager, Julius Mueller, Bettina Stritzke, Nahid S.M. Montazeri, Karel Caca, Evelien Dekker, Paul Fockens, Arthur Schmidt, Barbara A.J. Bastiaansen, David Albers, Hanneke Beaumont, Frank C. Bekkering, A. Bielich, Jurjen J. Boonstra, Frank ter Borg, Philip Bos, Geert Bulte, M Caselitz, U Denzer, Thomas Frieling, Eric A. R. Gielisse, Annuska M. Glas, Anne Glitsch, S. Hasberg, Wouter L. Hazen, C. Hofmann, M.H.M. G. Houben, W. Rogier ten Hove, Georg Hübner, G. Kähler, T. Kirchner, Martin Knöll, Albrecht Lorenz, Benjamin Meier, Marco W. Mundt, W. B. Nagengast, L Perk, R. Quispel, Francisco Javier Rando Munoz, Michael Repp, Rogier J. J. de Ridder, S.T. Rietdijk, Dieter Scholz, R. M. Schreuder, Matthijs P. Schwartz, Tom Seerden, Hedwig van der Sluis, Bas W. van der Spek, J.W.A. Straathof, J S Terhaar Sive Droste, Ciril Triller, M. S. Vlug, Wim van de Vrie, Dorothea Wagner, Benjamin Walter, Ingo Wallstabe, Andreas Wannhoff, Bas L. Weusten, Thomas R. de Wijkerslooth, M. Wilhelm, Hugo J. Wolters, Philipp Zervoulakos
Abstract
BACKGROUND AND AIMS: Endoscopic full-thickness resection (eFTR) is emerging as a minimally invasive alternative to surgery for complex colorectal lesions. Previous studies have demonstrated favorable safety results; however, large studies representing a generalizable estimation of adverse events (AEs) are lacking. Our aim was to provide further insight in AEs after eFTR. METHODS: Data from all registered eFTR procedures in the German and Dutch colorectal full-thickness resection device registries between July 2015 and March 2021 were collected. Safety outcomes included immediate and late AEs. RESULTS: Of 1892 procedures, the overall AE rate was 11.3% (213/1892). No AE-related mortality occurred. Perforations occurred in 2.5% (47/1892) of all AEs, 57.4% (27/47) of immediate AEs, and 42.6% (20/47) of delayed AEs. Successful endoscopic closure was achieved in 29.8% of cases (13 immediate and 1 delayed), and antibiotic treatment was sufficient in 4.3% (2 delayed). The appendicitis rate for appendiceal lesions was 9.9% (13/131), and 46.2% (6/13) could be treated conservatively. The severe AE rate requiring surgery was 2.2% (42/1892), including delayed perforations in .9% (17/1892) and immediate perforations in .7% (13/1892). Delayed perforations occurred between days 1 and 10 (median, 2) after eFTR, and 58.8% (10/17) were located on the left side. Other severe AEs were appendicitis (.4%, 7/1892), luminal stenosis (.1%, 2/1892), delayed bleeding (.1%, 1/1892), pain after eFTR close to the dentate line (.1%, 1/1892), and grasper entrapment in the clip (.1%, 1/1892). CONCLUSIONS: Colorectal eFTR is a safe procedure with a low risk for severe AEs in everyday practice and without AE-related mortality. These results further support the position of eFTR as an established minimally invasive technique for complex colorectal lesions.