Nonthermal resection device for ablation of Barrett’s esophagus: a feasibility and safety study

Abstract

Background Several techniques exist for the eradication of Barrett’s esophagus (BE); however, all have limitations regarding successful conversion to squamous epithelium and a complication profile. We aimed to assess the feasibility and safety of a new nonthermal device, the EndoRotor, for the eradication of BE as a first-line ablation technique.

Methods Patients with BE were prospectively included at two tertiary referral centers in The Netherlands. Inclusion criteria: BE length 2–5 cm, with low grade dysplasia, high grade dysplasia, or residual BE after endoscopic resection (ER) of a lesion containing early neoplasia. Exclusion criteria: previous ER > 50 % circumference, or previous ablation therapy. Follow-up endoscopy was performed 3 months after ablation therapy. Outcomes were the percentage of endoscopically visible BE surface regression and complications.

Results 30 patients were included (age 66 years, interquartile range [IQR] 59–73, median BE C0M3, 25 male). Overall, 18 patients underwent ER prior to ablation. Median percentage BE ablated was 100 % (IQR 94 %–100 %). Median visual BE surface regression at 3-month follow-up was 80 % (IQR 68 %–95 %). Multiple residual Barrett’s islands were commonly seen. Six patients (20 %) had a treatment-related complication requiring intervention, including one perforation (3 %), one postprocedural hemorrhage (3 %), and four strictures (13 %). Post-procedural pain was reported in 18 patients (60 %).

Conclusions Endoscopic ablation of BE using this novel nonthermal device was found to be technically demanding, with a longer procedure time compared with established ablation techniques and a high complication rate. Based on these results, we do not recommend its use as a first-line ablation technique for the eradication of BE.

^* Co-first authors

Publikationsverlauf

Eingereicht: 06. Februar 2021

Angenommen nach Revision: 14. September 2021

Accepted Manuscript online:
14. September 2021

Artikel online veröffentlicht:
21. Dezember 2021

• References

• 1 Lagergren J, Bergstrom R, Lindgren A. et al. Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma. N Engl J Med 1999; 340: 825-831
• 2 Peters Y, Al-Kaabi A, Shaheen NJ. et al. Barrett oesophagus. Nat Rev Dis Primers 2019; 5: 35
• 3 Kastelein F, Spaander MCW, Biermann K. et al. Role of acid suppression in the development and progression of dysplasia in patients with Barrett’s esophagus. Dig Dis 2011; 29: 499-506
• 4 Weusten B, Bisschops R, Coron E. et al. Endoscopic management of Barrett’s esophagus: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy 2017; 49: 191-198
• 5 Fitzgerald RC, di Pietro M, Ragunath K. et al. British Society of Gastroenterology guidelines on the diagnosis and management of Barrett’s oesophagus. Gut 2014; 63: 7-42
• 6 Shaheen NJ, Falk GW, Iyer PG. et al. ACG Clinical Guideline: Diagnosis and management of Barrett’s esophagus. Am J Gastroenterol 2016; 111: 30-50
• 7 van Vilsteren FG, Pouw RE, Seewald S. et al. Stepwise radical endoscopic resection versus radiofrequency ablation for Barrett’s oesophagus with high-grade dysplasia or early cancer: a multicentre randomised trial. Gut 2011; 60: 765-773
• 8 Wani S, Qumseya B, Sultan S. et al. Endoscopic eradication therapy for patients with Barrett’s esophagus-associated dysplasia and intramucosal cancer. Gastrointest Endosc 2018; 87: 907-931
• 9 Alvarez Herrero L, Pouw RE, van Vilsteren FG. et al. Safety and efficacy of multiband mucosectomy in 1060 resections in Barrett’s esophagus. Endoscopy 2011; 43: 177-183
• 10 Qumseya BJ, Wani S, Desai M. et al. Adverse events after radiofrequency ablation in patients with Barrett’s esophagus – a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2016; 14: 1086-1095
• 11 Fleischer DE, Sharma VK. Endoscopic ablation of Barrett’s esophagus using the Halo system. Dig Dis 2009; 26: 280-284
• 12 Shaheen NJ, Sharma P, Overholt BF. et al. Radiofrequency ablation in Barrett’s esophagus with dysplasia. N Engl J Med 2009; 360: 2277-2288
• 13 Phoa KN, Pouw RE, Bisschops R. et al. Multimodality endoscopic eradication for neoplastic Barrett oesophagus: results of an European multicentre study (EURO-II). Gut 2016; 65: 555-562
• 14 Frederiks CN, Canto MI, Weusten B. Updates in cryotherapy for Barrett’s esophagus. Gastrointest Endosc Clin N Am 2021; 31: 155-170
• 15 Hollerbach S, Wellmann A, Meier P. et al. The EndoRotorÒ: endoscopic mucosal resection system for non-thermal and rapid removal of esophageal, gastric, and colonic lesions: initial experience in live animals. Endosc Int Open 2016; 4: E475-479
• 16 Knabe M, Blößer S, Wetzka J. et al. Non-thermal ablation of non-neoplastic Barrett’s esophagus with the novel EndoRotor resection device. United European Gastroenterol J 2018; 6: 678-683
• 17 Sharma P, Dent J, Armstrong D. et al. The development and validation of an endoscopic grading system for Barrett’s esophagus: the Prague C & M criteria. Gastroenterology 2006; 131: 1392-1399
• 18 Schlemper RJ, Riddell RH, Kato Y. et al. The Vienna classification of gastrointestinal epithelial neoplasia. Gut 2000; 47: 251-255
• 19 Ogilvie AL, Dronfield MW, Ferguson R. et al. Palliative intubation of oesophagogastric neoplasms at fibreoptic endoscopy. Gut 1982; 23: 1060-1067
• 20 van Vilsteren FG, Phoa KN, Alvarez Herrero L. et al. Circumferential balloon-based radiofrequency ablation of Barrett’s esophagus with dysplasia can be simplified, yet efficacy maintained, by omitting the cleaning phase. Clin Gastroenterol Hepatol 2013; 11: 491-498
• 21 van Vilsteren FG, Alvarez Herrero L, Pouw RE. et al. Predictive factors for initial treatment response after circumferential radiofrequency ablation for Barrett’s esophagus with early neoplasia: a prospective multicenter study. Endoscopy 2013; 45: 516-525
• 22 Belghazi K, Pouw RE, Koch AD. et al. Self-sizing radiofrequency ablation balloon for eradication of Barrett’s esophagus: results of an international multicenter randomized trial comparing 3 different treatment regimens. Gastrointest Endosc 2019; 90: 415-423
• 23 Canto MI, Shaheen NJ, Almario JA. et al. Multifocal nitrous oxide cryoballoon ablation with or without EMR for treatment of neoplastic Barrett’s esophagus (with video). Gastrointest Endosc 2018; 88: 438-446
• 24 Canto MI, Shin EJ, Khashab MA. et al. Safety and efficacy of carbon dioxide cryotherapy for treatment of neoplastic Barrett’s esophagus. Endoscopy 2015; 47: 582-591
• 25 Shaheen NJ, Greenwald BD, Peery AF. et al. Safety and efficacy of endoscopic spray cryotherapy for Barrett’s esophagus with high-grade dysplasia. Gastrointest Endosc 2010; 71: 680-685
• 26 Visrodia K, Zakko L, Singh S. et al. Cryotherapy for persistent Barrett’s esophagus after radiofrequency ablation: a systematic review and meta-analysis. Gastrointest Endosc 2018; 87: 1396-1404
• 27 van Munster SN, Overwater A, Haidry R. et al. Focal cryoballoon versus radiofrequency ablation of dysplastic Barrett’s esophagus: impact on treatment response and postprocedural pain. Gastrointest Endosc 2018; 88: 795-803
• 28 Sengupta N, Ketwaroo GA, Bak DM. et al. Salvage cryotherapy after failed radiofrequency ablation for Barretts esophagus-related dysplasia is safe and effective. Gastrointest Endosc 2015; 82: 443-448
• 29 Solomon SS, Kothari S, Smallfield GB. et al. Liquid nitrogen spray cryotherapy is associated with less postprocedural pain than radiofrequency ablation in Barrett’s esophagus: a multicenter prospective study. J Clin Gastroenterol 2019; 53: e84-e90
• 30 Zemlyak AY, Pacicco T, Mahmud EM. et al. Radiofrequency ablation offers a reliable surgical modality for the treatment of Barrett’s esophagus with a minimal learning curve. Am Surg 2012; 78: 774-778
• 31 Peerally MF, Bhandari P, Ragunath K. et al. Radiofrequency ablation compared with argon plasma coagulation after endoscopic resection of high-grade dysplasia or stage T1 adenocarcinoma in Barrett’s esophagus: a randomized pilot study (BRIDE). Gastrointest Endosc 2019; 89: 680-689
• 32 Hussein M, Sami S, Lovat L. et al. Prospective multicentre randomised controlled trial comparing the safety and effectiveness of the EndoRotor mucosal resection device with continued ablation in the treatment of refractory Barrett’s oesophagus: report of initial outcomes. Gastrointest Endosc 2020; 91: AB414
• 33 ClinicalTrials.gov. EndoRotor resection in refractory Barrett’s dysplasia patients. https://clinicaltrials.gov/ct2/show/NCT03364114?cond=EndoRotor&draw=2&rank=5