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

Endoscopy. 2022 Jun;54(6):545-552. doi: 10.1055/a-1644-4326. Epub 2021 Dec 21.

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.

Trial registration: ClinicalTrials.gov NCT03120195.

Publication types

  • Clinical Trial

MeSH terms

  • Ablation Techniques* / adverse effects
  • Aged
  • Barrett Esophagus* / pathology
  • Catheter Ablation* / adverse effects
  • Catheter Ablation* / methods
  • Esophageal Neoplasms* / surgery
  • Esophagoscopy / adverse effects
  • Esophagoscopy / methods
  • Feasibility Studies
  • Follow-Up Studies
  • Humans
  • Hyperplasia / etiology
  • Male
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT03120195