Prospective Registration of endoscopic Full Thickness Resection in the Netherlands

Most benign colorectal polyps can be endoscopically removed with conventional polypectomy techniques, including piecemeal endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD). However, these techniques are limited to the superficial layers of the colonic wall and although sufficient in the majority of cases, a subset of lesions cannot be treated conventionally. These difficult to remove colorectal polyps consist of large (≥40 mm) flat lesions, non-lifting lesions, or lesions located at difficult anatomic locations involving the ileocecal valve, a diverticulum or the appendiceal orifice.



In order to overcome some of the technical challenges of the endoscopic removal of complex lesions a novel endoscopic device has been developed to perform endoscopic full-thickness resection (eFTR) with immediate secure defect closure. This full-thickness resection device (FTRD, Ovesco Endoscopy, Tübingen, Germany) consists of a modified over-the-scope clip (OTSC) mounted on a cap with a preloaded snare. It has been investigated in preclinical trials and a recent clinical case series of 25 colorectal lesions. However more clinical research is needed to further investigate the clinical applicability, technical success rates and safety of performing eFTR with the FTRD. Therefore we will perform a prospective registration of all scheduled eFTR procedures with the FTRD in the Netherlands to further investigate the applicability, technical success rates and safety of this device. The technical success of all scheduled eFTR procedures in the Netherlands is defined as the number of endoscopic complete en bloc resections and the number of histologically confirmed R0 and full-thickness resection. The applicability and safety of all scheduled eFTR procedures will studied when investigating the number of scheduled eFTR procedues that were note completely performed, procedural time, complication rates and the occurrence of local recurrence during surveillance colonoscopies.

We aim to study the applicability, safety and technical success of all scheduled eFTR procedures in the Netherlands.

01-06-2017: evaluation of 6 months inclusion period

01-01-2018: evaluation of a one year inclusion period

There will be no formal interventions in this study, since this is a prospective registration of endoscopic full-thickness resection, wherefore the indication for this procedure is already set by an trained endoscopist.