PMID- 33015330 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20201006 IS - 2364-3722 (Print) IS - 2196-9736 (Electronic) IS - 2196-9736 (Linking) VI - 8 IP - 10 DP - 2020 Oct TI - Full-thickness resection device (FTRD) for treatment of upper gastrointestinal tract lesions: the first international experience. PG - E1291-E1301 LID - 10.1055/a-1216-1439 [doi] AB - Background and study aims The Full-Thickness Resection Device (FTRD) provides a novel treatment option for lesions not amenable to conventional endoscopic resection techniques. There are limited data on the efficacy and safety of FTRD for resection of upper gastrointestinal tract (GIT) lesions. Patients and methods This was an international multicenter retrospective study, including patients who had an endoscopic resection of an upper GIT lesion using the FTRD between January 2017 and February 2019. Results Fifty-six patients from 13 centers were included. The most common lesions were mesenchymal neoplasms (n = 23, 41 %), adenomas (n = 7, 13 %), and hamartomas (n = 6, 11 %). Eighty-four percent of lesions were located in the stomach, and 14 % in the duodenum. The average size of lesions was 14 mm (range 3 to 33 mm). Deployment of the FTRD was technically successful in 93 % of patients (n = 52) leading to complete and partial resection in 43 (77 %) and 9 (16 %) patients, respectively. Overall, the FTRD led to negative histological margins (R0 resection) in 38 (68 %) of patients. A total of 12 (21 %) mild or moderate adverse events (AEs) were reported. Follow-up endoscopy was performed in 31 patients (55 %), on average 88 days after the procedure (IQR 68-138 days). Of these, 30 patients (97 %) did not have any residual or recurrent lesion on endoscopic examination and biopsy, with residual adenoma in one patient (3 %). Conclusions Our results suggest a high technical success rate and an acceptable histologically complete resection rate, with a low risk of AEs and early recurrence for FTRD resection of upper GIT lesions. CI - The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/). FAU - Hajifathalian, Kaveh AU - Hajifathalian K AD - Weill Cornell Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, New York, NY. FAU - Ichkhanian, Yervant AU - Ichkhanian Y AD - Division of Gastroenterology, Johns Hopkins Hospital, Baltimore, Maryland, United States. FAU - Dawod, Qais AU - Dawod Q AD - Weill Cornell Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, New York, NY. FAU - Meining, Alexander AU - Meining A AD - Interventional and Experimental Endoscopy, Department of Internal Medicine I, Ulm University, Ulm, Germany. FAU - Schmidt, Arthur AU - Schmidt A AD - Department of Medicine II, Medical Center, University of Freiburg, Faculty of Medicine, Freiburg, Germany. FAU - Glaser, Nicholas AU - Glaser N AD - Department of Medicine II, Medical Center, University of Freiburg, Faculty of Medicine, Freiburg, Germany. FAU - Vosoughi, Kia AU - Vosoughi K AD - Division of Gastroenterology, Johns Hopkins Hospital, Baltimore, Maryland, United States. FAU - Diehl, David L AU - Diehl DL AD - Interventional and Experimental Endoscopy, Department of Internal Medicine I, Ulm University, Ulm, Germany. FAU - Grimm, Ian S AU - Grimm IS AD - Department of Gastroenterology and Nutrition, Geisinger Medical Center, Danville, Pennsylvania, United States. FAU - James, Theodore AU - James T AD - Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina, United States. FAU - Templeton, Adam W AU - Templeton AW AD - Department of Gastroenterology, University of Washington, Seattle, Washington, United States. FAU - Samarasena, Jason B AU - Samarasena JB AD - H. H. Chao Comprehensive Digestive Disease Center, Division of Gastroenterology and Hepatology, University of California, Irvine, Orange, California, United States. FAU - Chehade, Nabil El Hage AU - Chehade NEH AD - H. H. Chao Comprehensive Digestive Disease Center, Division of Gastroenterology and Hepatology, University of California, Irvine, Orange, California, United States. FAU - Lee, John G AU - Lee JG AD - H. H. Chao Comprehensive Digestive Disease Center, Division of Gastroenterology and Hepatology, University of California, Irvine, Orange, California, United States. FAU - Chang, Kenneth J AU - Chang KJ AD - H. H. Chao Comprehensive Digestive Disease Center, Division of Gastroenterology and Hepatology, University of California, Irvine, Orange, California, United States. FAU - Mizrahi, Meir AU - Mizrahi M AD - Department of Internal Medicine, Division of Gastroenterology, Center for Advanced Endoscopy, University of South Alabama, Mobile, Alabama, United States. FAU - Barawi, Mohammed AU - Barawi M AD - Division of Gastroenterology and Hepatology, Ascension St. John hospital, Detroit, Michigan, United States. FAU - Irani, Shayan AU - Irani S AD - Digestive Disease Institute, Virginia Mason Medical Center, Seattle, Washington, United Stats. FAU - Friedland, Shai AU - Friedland S AD - Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, California, United States. FAU - Korc, Paul AU - Korc P AD - Department of Medicine, Division of Gastroenterology, Hoag Hospital, Newport Beach, California, United States. FAU - Aadam, Abdul Aziz AU - Aadam AA AD - Division of Gastroenterology, Northwestern University, Chicago, Illinois, United States. FAU - Al-Haddad, Mohammad AU - Al-Haddad M AD - Indiana University School of Medicine, Department of Medicine, Division of Gastroenterology, Indianapolis, Indiana, United States. FAU - Kowalski, Thomas E AU - Kowalski TE AD - Thomas Jefferson University, Philadelphia, Pennsylvania, United States. FAU - Smallfield, George AU - Smallfield G AD - Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, Virginia United States. FAU - Ginsberg, Gregory G AU - Ginsberg GG AD - Gastroenterology Division, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania, United States. FAU - Fukami, Norio AU - Fukami N AD - Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, Scottsdale, Arizona, United States. FAU - Lajin, Michael AU - Lajin M AD - SHARP Grossmont Hospital, La Mesa, California, United States. FAU - Kumta, Nikhil A AU - Kumta NA AD - Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, United States. FAU - Tang, Shou-Jiang AU - Tang SJ AD - Division of Digestive Diseases, Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, United States. FAU - Naga, Yehia AU - Naga Y AD - Division of Digestive Diseases, Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, United States. FAU - Amateau, Stuart K AU - Amateau SK AD - Division of Gastroenterology, University of Minnesota, Minneapolis, Minnesota, United States. FAU - Kasmin, Franklin AU - Kasmin F AD - Division of Gastroenterology, Lenox Hill Hospital, Northwell Health, New York, New York, United States. FAU - Goetz, Martin AU - Goetz M AD - Innere Medizin I, Universitatsklinikum Tubingen, Tuebingen, Germany. FAU - Seewald, Stefan AU - Seewald S AD - Centre of Gastroenterology, Klinik Hirslanden, Zurich, Switzerland. FAU - Kumbhari, Vivek AU - Kumbhari V AD - Division of Gastroenterology, Johns Hopkins Hospital, Baltimore, Maryland, United States. FAU - Ngamruengphong, Saowanee AU - Ngamruengphong S AD - Division of Gastroenterology, Johns Hopkins Hospital, Baltimore, Maryland, United States. FAU - Mahdev, Srihari AU - Mahdev S AD - Weill Cornell Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, New York, NY. FAU - Mukewar, Saurabh AU - Mukewar S AD - Weill Cornell Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, New York, NY. FAU - Sampath, Kartik AU - Sampath K AD - Weill Cornell Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, New York, NY. FAU - Carr-Locke, David L AU - Carr-Locke DL AD - Weill Cornell Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, New York, NY. FAU - Khashab, Mouen A AU - Khashab MA AD - Division of Gastroenterology, Johns Hopkins Hospital, Baltimore, Maryland, United States. FAU - Sharaiha, Reem Z AU - Sharaiha RZ AD - Weill Cornell Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, New York, NY. LA - eng PT - Journal Article DEP - 20200922 PL - Germany TA - Endosc Int Open JT - Endoscopy international open JID - 101639919 PMC - PMC7508667 COIS- Competing interests Dr. Khashab is a consultant for Boston Scientific, Medtronic and Olympus. Dr. 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 is a consultant for Boston Scientific. Dr. Diehl is a consultant for Boston Scientific, Olympus, Pentax, and Cook Medical. Dr. Chang is a consultant for Apollo, Boston Scientific, Cook, Covidien, Erbe, Endogastric Solutions, Mauna Kea Technologies, Mederi, Medtronic, Olympus, Ovesco, Pentax, and Torax. Dr. Samarasena has an educational grant from Cook and is a consultant for Mauna Kea Technologies, Medtronic, Olympus, Pentax, and US Endoscopy. Dr. Al-Haddad received research and teaching support from Boston Scientific. Dr. Friedland is a consultant for Boston Scientific and CapsoVision. Dr. Templeton is a consultant for Boston Scientific and Medtronic. Dr. Ginsberg is a consultant for Olympus and Boston Scientific. Dr. Fukami is a consultant for Boston Scientific and Olympus. Dr. Mahadev is a consultant for Olympus and Conmed. Dr Sharaiha is a consultant for Olympus, Boston Scientific, and Cook. Dr Carr-Locke is a consultant for Boston Scientific Endoscopy and receives royalties from Steris Corporation and Telemed Systems. Dr. Schmidt has received lecture fees and research funding from Ovesco Endoscopy. EDAT- 2020/10/06 06:00 MHDA- 2020/10/06 06:01 PMCR- 2020/10/01 CRDT- 2020/10/05 06:22 PHST- 2020/03/03 00:00 [received] PHST- 2020/06/29 00:00 [accepted] PHST- 2020/10/05 06:22 [entrez] PHST- 2020/10/06 06:00 [pubmed] PHST- 2020/10/06 06:01 [medline] PHST- 2020/10/01 00:00 [pmc-release] AID - 10.1055/a-1216-1439 [doi] PST - ppublish SO - Endosc Int Open. 2020 Oct;8(10):E1291-E1301. doi: 10.1055/a-1216-1439. Epub 2020 Sep 22.