Prospective feasibility study of a novel rigidizing stabilizing overtube in the resection of complex gastrointestinal polyps

Abstract

Background A novel rigidizing overtube (ROT) was developed to facilitate endoscopic removal of complex gastrointestinal polyps. We aimed to prospectively evaluate the efficacy and safety of the device in the management of large gastrointestinal polyps.

Methods A prospective, single-center study, conducted between May 2021 and April 2023, enrolled patients undergoing endoscopic resection of colon/duodenal polyps ≥25 mm. Primary outcomes were safety, technical success, and clinical success defined as the ability of ROT to facilitate endoscopic polyp removal without changing the initial resection method.

Results 97 patients (98 polyps), with a mean polyp size of 33.2 mm (median 31.1), were evaluated. Technical and clinical success rates were 100% and 84%, respectively. Ileocecal valve location was the only predictor of clinical failure (P = 0.02). The mean time to reach the lesion was 7.2 minutes (95%CI 5–8), with overall resection and procedure times of 53.6 minutes (95%CI 48–61) and 88.9 minutes (95%CI 79–95), respectively. No device-related adverse events occurred. Lower technical (67%) and clinical (67%) success rates were seen for duodenal polyps (n = 6).

Conclusion The novel ROT was safe, with high technical and clinical success during resection of complex colon polyps. Future studies will determine timing of implementation during routine endoscopic resection.

Publication History

Received: 06 October 2023

Accepted after revision: 10 June 2024

Article published online:
11 July 2024

• References

• 1 Zauber AG, Winawer SJ, O’Brien MJ. et al. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med 2012; 366: 687-696 DOI: 10.1056/NEJMoa1100370. (PMID: 22356322)
• 2 Iishi H, Tatsuta M, Iseki K. et al. Endoscopic piecemeal resection with submucosal saline injection of large sessile colorectal polyps. Gastrointest Endosc 2000; 51: 697-700
• 3 Wang J, Zhang X-H, Ge J. et al. Endoscopic submucosal dissection vs endoscopic mucosal resection for colorectal tumors: a meta-analysis. World J Gastroenterol 2014; 20: 8282-8287 DOI: 10.3748/wjg.v20.i25.8282. (PMID: 25009404)
• 4 Pohl H, Srivastava A, Bensen SP. et al. Incomplete polyp resection during colonoscopy – results of the complete adenoma resection (CARE) study. Gastroenterology 2013; 144: 74-80
• 5 Yoshida N, Naito Y, Murakami T. et al. Tips for safety in endoscopic submucosal dissection for colorectal tumors. Ann Transl Med 2017; 5: 185 DOI: 10.21037/atm.2017.03.33. (PMID: 28616400)
• 6 Aslan F, Seren AR, Akpinar Z. et al. The usage of overtube has a favorable effect on endoscopic submucosal dissection. Surg Endosc 2015; 29: 2561-2568 DOI: 10.1007/s00464-014-3968-x. (PMID: 25427415)
• 7 Kim SH. Usefulness of an overtube device in gastrointestinal endoscopy. Clin Endosc 2019; 52: 203 DOI: 10.5946/ce.2019.085. (PMID: 31154698)
• 8 Othman MO, Jawaid SA, Rungta M. et al. Double-balloon endolumenal intervention platform with flexible grasper to expedite colonic endoscopic submucosal dissection. VideoGIE 2020; 26; 6: 144-146
• 9 Wei MT, Hwang JH, Watson RR. et al. Novel rigidizing overtube for colonoscope stabilization and loop prevention (with video). Gastrointest Endosc 2021; 93: 740-749
• 10 Abadir AP, Park N, Eng D. et al. Successful use of a novel dynamic rigidizing overtube in a patient with looping during colonoscopy. VideoGIE 2021; 6: 236-238
• 11 Coronel M, Coronel E, Romero L. et al. Combination of a dynamic rigidizing overtube and a novel injectable needle-type knife to facilitate colorectal endoscopic submucosal dissection. VideoGIE 2021; 6: 297-300 DOI: 10.1016/j.vgie.2021.02.013. (PMID: 34278090)
• 12 Ahmed Y, Othman M. EMR/ESD: techniques, complications, and evidence. Curr Gastroenterol Rep 2020; 22: 1-12 DOI: 10.1007/s11894-020-00777-z. (PMID: 32542462)
• 13 Sakamoto H, Hayashi Y, Miura Y. et al. Pocket-creation method facilitates endoscopic submucosal dissection of colorectal laterally spreading tumors, non-granular type. Endosc Int Open 2017; 5: E123-E129 DOI: 10.1055/s-0042-122778. (PMID: 28337483)
• 14 Aslan F, Akpinar Z, Kucuk M. et al. Single tunneling technique for treatment of giant laterally spreading tumor with endoscopic submucosal dissection. VideoGIE 2017; 2: 155-157
• 15 Ronnow CF, Uedo N, Toth E. et al. Endoscopic submucosal dissection of 301 large colorectal neoplasias: outcome and learning curve from a specialized center in Europe. Endosc Int Open 2018; 6: E1340-1348
• 16 Tidehag V, Tornqvist B, Pekkari K. et al. Endoscopic submucosal dissection for removal of large colorectal neoplasias in an outpatient setting: a single center series of 660 procedures in Sweden. Gastrointest Endosc 2022; 96: 101-107 DOI: 10.1016/j.gie.2022.02.017. (PMID: 35217016)
• 17 Seo M, Yang DH, Kim J. et al. Clinical outcomes of colorectal endoscopic submucosal dissection and risk factors associated with piecemeal resection. Turk J Gastroenterol 2018; 29: 473-480
• 18 Keihanian T, Othman MO. Colorectal endoscopic submucosal dissection: an update on best practice. Clin Exp Gastroenterol 2021; 14: 317-330 DOI: 10.2147/CEG.S249869. (PMID: 34377006)
• 19 Jeon HH, Lee HS, Youn YH. et al. Learning curve analysis of colorectal endoscopic submucosal dissection (ESD) for laterally spreading tumors by endoscopists experienced in gastric ESD. Surg Endosc 2016; 30: 2422-2430 DOI: 10.1007/s00464-015-4493-2. (PMID: 26423415)
• 20 Ferlitsch M, Moss A, Hassan C. et al. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy 2017; 49: 270-297 DOI: 10.1055/s-0043-102569. (PMID: 28212588)