Objective Endoscopic full-thickness resection (EFTR) is a novel treatment of colorectal lesions not amenable to conventional endoscopic resection. The aim of this prospective multicentre study was to assess the efficacy and safety of the full-thickness resection device.
Design 181 patients were recruited in 9 centres with the indication of difficult adenomas (non-lifting and/or at difficult locations), early cancers and subepithelial tumours (SET). Primary endpoint was complete en bloc and R0 resection.
Results EFTR was technically successful in 89.5%, R0 resection rate was 76.9%. In 127 patients with difficult adenomas and benign histology, R0 resection rate was 77.7%. In 14 cases, lesions harboured unsuspected cancer, another 15 lesions were primarily known as cancers. Of these 29 cases, R0 resection was achieved in 72.4%; 8 further cases had deep submucosal infiltration >1000 µm. Therefore, curative resection could only be achieved in 13/29 (44.8%). In the subgroup with SET (n=23), R0 resection rate was 87.0%. In general, R0 resection rate was higher with lesions ≤2 cm vs >2 cm (81.2% vs 58.1%, p=0.0038). Adverse event rate was 9.9% with a 2.2% rate of emergency surgery. Three-month follow-up was available from 154 cases and recurrent/residual tumour was evident in 15.3%.
Conclusion EFTR has a reasonable technical efficacy especially in lesions ≤2 cm with acceptable complication rates. Curative resection rate for early cancers was too low to recommend its primary use in this indication. Further comparative studies have to show the clinical value and long-term outcome of EFTR in benign colorectal lesions.
Trial registration number NCT02362126; Results.
- endoscopic full-thickness resection
- non-lifting adenomas
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Contributors AS wrote the study protocol, was responsible for conductance of the study at Klinikum Ludwigsburg, coordinated the study centers, analysed the data and wrote the manuscript draft. KC was the sponsor of the study, participated in writing the study protocol, analysing the data and writing the manuscript draft. All other authors enrolled and treated patients at the study sites, and critically reviewed the manuscript.
Competing interests The coordinating centre and the participating centres received financial support for case documentation and costs from Ovesco Endoscopy. AS and KC received lecture fees from Ovesco Endoscopy.
Ethics approval Ethics comittee/Landesärztekammer Nord-Württemberg.
Provenance and peer review Not commissioned; internally peer reviewed.
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