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DOI: 10.1055/a-2085-3757
Settings of a novel electrosurgical generator to enable efficient and safe submucosal endoscopic procedures
Gefördert durch: ConMed 2233368516TRIAL REGISTRATION: Registration number (trial ID): NCT04752670, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Prospective
Abstract
Background and study aims A novel electrosurgical generator unit (ESU), ConMed Beamer, was recently introduced to facilitate endoscopic submucosal dissection (ESD) by employing Automatic Cutting Effect (ACE) technology. Its use in submucosal endoscopy has yet to be investigated. The aim of this study was to evaluate the feasibility and safety of performing ESD and peroral endoscopic myotomy (POEM) using novel settings generated with ConMed Beamer ESU.
Patients and methods This was a single-center prospective study of 59 consecutive patients undergoing ESD/POEM at a tertiary referral center. ESU settings were initially generated by testing in live animal models prior to first in-human study. The primary outcome was technical success. Secondary outcomes were procedure times, rate of en bloc/R0 resection, and rate of adverse events (AEs).
Results A total of 44 patients (50 polyps) and 15 patients underwent ESD and POEM, respectively. En bloc resection, R0 resection, and curative resection rates were 90%, 77.1%, and 70.8%, respectively. Mean maximal length of the lesion was 3.07 cm ± 1.43 with an average dissection speed of 14.2 cm2/hr ± 11.1. Technical success was achieved in 100% of POEM patients. Mean time (minutes) to complete the POEM procedure was 50.1 min ± 12.4. Two major AEs occurred among all patients (3.4%). All intraprocedural bleeding events were controlled using the ConMed Beamer ESU.
Conclusions ConMed Beamer ESU settings generated from this study were proven safe and effective in a prospective cohort of patients who underwent submucosal endoscopic procedures. This novel ESU can be added to the armamentarium of ESD capable generators.
Publikationsverlauf
Eingereicht: 23. Januar 2023
Angenommen nach Revision: 18. April 2023
Accepted Manuscript online:
03. Mai 2023
Artikel online veröffentlicht:
16. August 2023
© 2023. 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 commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
Georg Thieme Verlag KG
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References
- 1 Pimentel-Nunes P, Dinis-Ribeiro M, Ponchon T. et al. Endoscopic submucosal dissection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2015; 47: 829-854
- 2 Morita Y. Electrocautery for ESD: settings of the electrical surgical unit VIO300D. Gastrointest Endosc Clin N Am 2014; 24: 183-189
- 3 Ko BM. History and development of accessories for endoscopic submucosal dissection. Clin Endosc 2017; 50: 219-223
- 4 Tonai Y, Ishihara R, Yamasaki Y. et al. Impact of electrosurgical unit mode on post esophageal endoscopic submucosal dissection stricture in an in vivo porcine model. Endosc Int Open 2018; 6: E376-E381
- 5 Odagiri H, Yasunaga H. Complications following endoscopic submucosal dissection for gastric, esophageal, and colorectal cancer: a review of studies based on nationwide large-scale databases. Ann Transl Medicine 2017; 5: 189-190
- 6 Fukuhara S, Kato M, Iwasaki E. et al. Management of perforation related to endoscopic submucosal dissection for superficial duodenal epithelial tumors. Gastrointest Endosc 2020; 91: 1129-1137
- 7 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
- 8 Ono H, Yao K, Fujishiro M. et al. Guidelines for endoscopic submucosal dissection and endoscopic mucosal resection for early gastric cancer. Dig Endosc 2016; 28: 3-15
- 9 Yoon JY, Kim JH, Lee JY. et al. Clinical outcomes for patients with perforations during endoscopic submucosal dissection of laterally spreading tumors of the colorectum. Surg Endosc 2013; 27: 487-493
- 10 Maple JT, Abu Dayyeh BK, Chauhan SS. et al. Endoscopic submucosal dissection. Gastrointest Endosc 2015; 81: 1311-1325
- 11 Saito Y, Mashimo III Y, Kikuchi T. et al. Endoscopic submucosal dissection resulted in higher en-bloc resection rates and reduced lower recurrence for LST >20mm compared to conventional EMR. Gastrointes Endo 2007; 65: PAB 273
- 12 Fleischmann C, Probst A, Ebigbo A. et al. Endoscopic submucosal dissection in Europe: results of 1000 neoplastic lesions from the German endoscopic submucosal dissection registry. Gastroenterology 2021; 161: 1168-1178
- 13 Zhang X, Ly EK, Nithyanand S. et al. Learning curve for endoscopic submucosal dissection with an untutored, prevalence-based approach in the United States. Clin Gastroenterol Hepatol 2020; 18: 580-588 e581
- 14 Jeong JY, Oh YH, Yu YH. et al. Does submucosal fibrosis affect the results of endoscopic submucosal dissection of early gastric tumors?. Gastrointest Endosc 2012; 76: 59-66
- 15 Kuroha M, Shiga H, Kanazawa Y. et al. Factors associated with fibrosis during colorectal endoscopic submucosal dissection: does pretreatment biopsy potentially elicit submucosal fibrosis and affect endoscopic submucosal dissection outcomes?. Digestion 2021; 102: 590-598
- 16 Fuccio L, Bhandari P, Maselli R. et al. Ten quality indicators for endoscopic submucosal dissection: what should be monitored and reported to improve quality. Ann Transl Med 2018; 6: 262
- 17 Pu LZCT, Yamamura T, Nakamura M. et al. Learning curve for mastery of colorectal endoscopic submucosal dissection: perspectives from a large Japanese cohort. JGH Open 2020; 4: 611-616
- 18 Marin-Gabriel JC, Romito R, Guarner-Argente C. et al. Use of electrosurgical units in the endoscopic resection of gastrointestinal tumors. Gastroenterol Hepatol 2019; 42: 512-523
- 19 Fukuhara S, Kato M, Iwasaki E. et al. Management of perforation related to endoscopic submucosal dissection for superficial duodenal epithelial tumors. Gastrointest Endosc 2020; 91: 1129-1137
- 20 Akahoshi K, Kubokawa M, Inamura K. et al. Current challenge: Endoscopic submucosal dissection of superficial non-ampullary duodenal epithelial tumors. Current Treatment Opt in Oncology 2020; 21: 98