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.
Bibliographical noteFunding Information:
Dr. Khashab is consultant for Boston Scientific, Medtronic, and Olympus. Dr. Ian Grimm is a consultant for Boston Scientific. Dr. Irani is a consultant for Boston Scientific. Dr. Kumbhari is a consultant for ReShape Life Sciences, Apollo Endosurgery, Medtronic, and Boston Scientific. Dr. Nikhil is a consultant for Apollo Endosurgery, Boston scientific, and Olympus. Dr. Amateau is a consultant for Merit Endoscopy, Boston Scientific, US Endoscopy, and Neurotronic and the recipient of research support from Cook Medical. Dr. Smallfield has research funding from CSA medical and C2 therapeutics. Dr. Aadam AA is a consultant for Boston Scientific. Dr. Diehl Md Consultant for Boston Scientific, Olympus, Pentax, Cook Medical, Merit, ConMed, US Endoscopy, Medtronic, Lumendi. Dr. Chang consultant for Apollo, Boston Scientific, Cook, Covidien, Erbe, Endogastric Solutions, Mauna Kea Mederi, Medtronic, Olympus, Ovesco, Pentax, Torax. Dr. Samarasena has educational grant from Cook and consultant for Mauna Kea, Medtronic, Olympus, Pentax, US Endoscopy. Dr. Al-Haddad received research and teaching support from Boston Scientific. Dr. Pohl received grants from Boston Scientific, US Endoscopy, and Aries/Cosmo Pharamceuticals. Dr. Templeton is a consultant for Boston Scientific and Medtronic. Dr. Ginsberg is a consultant for Olympus Inc. and Boston Scientific. Dr. Fukami is consultant for Boston Scientific and Olympus. Dr. Sharaiha is consultant for Boston Scientific, Olympus, Apollo, and Medtronic. Dr. Ichkhanian, Dr. Vosoughi, Dr. James, Dr. Hajifathalian, Dr. Tokar, Dr. Lee, Dr. Mizrahi, Dr. Barawi, Dr. Friedland, Dr. Korc, Dr. Kowalski, Dr. Novikov, Dr. Oza, Dr. Panuu, Dr. Lajin, Dr. Kumta, Dr. Tang, Dr. Naga, and Dr. Brewer have no conflicts of interest or financial ties to disclose
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- Difficult adenomas
- Endoscopic full-thickness resection
- Full-thickness resection device