Multicenter prospective evaluation of an overtube endoluminal interventional platform for colorectal polypectomy

Abstract

Background and study aims Endoscopic removal of complex colorectal polyps (≥ 2 cm) can be technically challenging. A dual balloon endoluminal overtube platform (DBEP) was developed to facilitate colonoscopic polypectomy. The study purpose was to evaluate clinical outcomes with the DBEP for complex polypectomy.

Patients and methods This was an observational, prospective, multicenter Institutional Review Board-approved study. Between January 2018 and December 2020, safety and performance data were collected intra-procedurally and at 1 month post-procedure in patients undergoing intervention with the DBEP at three US centers. The primary endpoint was device safety and technical success of the procedure. Secondary endpoints included navigation time, total procedure time, and user feedback assessment post-procedure.

Results A total of 162 patients underwent colonoscopy with the DBEP. Of these, 144 (89 %) underwent 156 interventions successfully with DBEP (44.5 % endoscopic mucosal resection, 53.2 % hybrid endoscopic submucosal dissection (ESD)/ESD, 1.3 % other). In 13 patients (8 %), device challenges contributed to unsuccessful intervention. One mild device-related adverse event (AE) occurred. Procedural AE rate was 8.3 %. Median lesion size was 2.6 cm [range 0.5–12]. The investigators felt that navigating the device was easy/somewhat easy in 78.5 % of successful cases. Median total procedure time was 69 minutes [range, 19–213], median navigation time to lesion was 8 minutes [range, 1–80], And median polypectomy time was 33.5 minutes [range, 2–143].

Conclusions Endoscopic colon polyp resection with the DBEP was safe with a high technical success rate. The DBEP has the potential to provide enhanced scope stability and visualization, traction, and a conduit for scope exchange. Further prospective randomized studies are warranted.

Publication History

Received: 01 August 2022

Accepted after revision: 10 February 2023

Accepted Manuscript online:
17 March 2023

Article published online:
17 May 2023

• References

• 1 Siegel RL, Fedewa SA, Anderson WF. et al. Colorectal cancer incidence patterns in the United States, 1974-2013. J Natl Cancer Inst 2017; 109
• 2 Nfonsam VN, Jecius H, Chen D. et al. Increasing incidence of colon cancer in the young: assessing the tumor biology. J Am Coll Surg 2019; 229: 79-903
• 3 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: 687-6964
• 4 Ismail MS, Bahdi F, Mercado MO. et al. ESD with double-balloon endoluminal intervention platform versus standard ESD for management of colon polyps. Endosc Int Open 2020; 8: E1273-E1279
• 5 Riff BP, DiMaio CJ. Exploring the small bowel: update on deep enteroscopy. Curr Gastroenterol Rep 2016; 18: 28
• 6 Swan MP, Bourke MJ, Alexander S. et al. Large refractory colonic polyps: is it time to change our practice? A prospective study of the clinical and economic impact of a tertiary referral colonic mucosal resection and polypectomy service (with videos).. Gastrointest Endosc 2009; 70: 1128-1136
• 7 Pohl H, Grimm IS, Moyer MT. et al. Clip closure prevents bleeding after endoscopic resection of large colon polyps in a randomized trial. Gastroenterology 2019; 157: 977-984 e973
• 8 Kantsevoy SV, Bitner M, Hajiyeva G. et al. Endoscopic management of colonic perforations: clips versus suturing closure (with videos). Gastrointest Endosc 2016; 84: 487-493
• 9 Othman MO, Jawaid SA, Rungta M. et al. Double-balloon endolumenal intervention platform with flexible grasper to expedite colonic endoscopic submucosal dissection. VideoGIE 2021; 6: 144-146