Efficacy and Safety of Endoscopic Full-Thickness Resection in the Colorectum: Results From the German Colonic FTRD Registry

Abstract

INTRODUCTION: Endoscopic full-thickness resection (EFTR) is a powerful option for resection of colorectal lesions not amenable to conventional endoscopic resection. The full-thickness resection device (FTRD) allows clip-assisted EFTR with a single-step technique. We report on results of a large nationwide FTRD registry. METHODS: The “German colonic FTRD registry” was created to further assess efficacy and safety of the FTRD System after approval in Europe. Data were analyzed retrospectively. RESULTS: Sixty-five centers contributed 1,178 colorectal FTRD procedures. Indications for EFTR were difficult adenomas (67.1%), early carcinomas (18.4%), subepithelial tumors (6.8%), and diagnostic EFTR (1.3%). Mean lesion size was 15 × 15 mm and most lesions were pretreated endoscopically (54.1%). Technical success was 88.2% and R0 resection was achieved in 80.0%. R0 resection was significantly higher for subepithelial tumor compared with that for other lesions. No difference in R0 resection was found for smaller vs larger lesions or for colonic vs rectal procedures. Adverse events occurred in 12.1% (3.1% major events and 2.0% required surgical treatment). Endoscopic follow-up was available in 58.0% and showed residual/recurrent lesions in 13.5%, which could be managed endoscopically in most cases (77.2%). DISCUSSION: To date, this is the largest study of colorectal EFTR using the FTRD System. The study demonstrated favorable efficacy and safety for “difficult-to-resect” colorectal lesions and confirms results of previous studies in a large “real-world” setting. Further studies are needed to compare EFTR with other advanced resection techniques and evaluate long-term outcome.

Endoscopic full-thickness resection of T1 colorectal cancers: a retrospective analysis from a multicenter Dutch eFTR registry

“…Several clinical studies on colorectal eFTR have been published, showing encouraging results in terms of safety and efficacy for various indications, including our first feasibility study [12][13][14][15][16][17][18].…”

Colorectal endoscopic full‐thickness resection: Initial experience from a tertiary centre in Singapore

“…15 Following this meta-analysis, a prospective Dutch registry on 367 colorectal EFTR 5 and retrospective German registry on 1178 colorectal EFTR 6 provided further evidence to support the use of EFTR, albeit with a slightly lower technical success rate of 84%-88%. 5,6 The reason for the high technical success rates and R0 resection rates in our study is because majority of lesions removed were small (<10 mm) NET in the rectum. Our results are in keeping with both the Dutch and German registries showing a significantly higher technical success and R0 resection rates for SET compared to adenoma.…”

“…Since the introduction of EFTR with FTRD into clinical practice, 3 there has been increasing number of published studies on EFTR using the FTRD system in the colorectum, mostly retrospective in nature from Europe. [4][5][6][7][8][9][10][11][12][13] A meta-analysis on 469 colorectal EFTR showed pooled technical success rates of 94.0% (95% confidence interval 89.8%-97.3%) and R0 resection rate 84.9% (75.1%-92.8%). 15 Following this meta-analysis, a prospective Dutch registry on 367 colorectal EFTR 5 and retrospective German registry on 1178 colorectal EFTR 6 provided further evidence to support the use of EFTR, albeit with a slightly lower technical success rate of 84%-88%.…”

“…3 Multiple studies have shown that this technique is efficacious and safe in lesions up to 3 cm, with favourable outcomes replicable in multiple centres. [4][5][6][7][8][9][10][11][12][13] Most of the published data are from Europe and there have been no prior studies on colorectal EFTR using FTRD in Asia. Therefore, we aimed to describe our experience and the clinical outcomes of this procedure performed in our centre.…”

Endoscopic full-thickness resection versus endoscopic submucosal dissection in the treatment of colonic neoplastic lesions ≤ 30 mm—a single-center experience

“…Endoscopic full-thickness resection (FTR) is a novel technique for transmural resection of the colorectal neoplastic lesions using combination of over-the-scope clip application and cap-assisted snare resection [1]. It has been proven effective in the treatment of neoplastic lesions with non-lifting during submucosal injection, suspected early cancer lesions, local residual neoplasia lesions, and small subepithelial tumors [2][3][4][5][6][7][8][9]. Major limitation of FTR is limited extent of resection; therefore, only flat lesions ≤ 30 mm may be successfully treated.…”