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DOI: 10.1055/s-0039-1681490
ENDOROTOR ABLATION OF BARRETT'S ESOPHAGUS; A SAFETY AND FEASIBILITY STUDY
Publication History
Publication Date:
18 March 2019 (online)
Aims:
The aim of this study was to assess the safety and efficacy of a novel, non-thermal resection device (EndoRotor) for the ablation of Barrett's esophagus (BE).
Methods:
Between January 2017 and September 2018, patients with BE were included from 2 tertiary referral centers. Inclusion criteria: BE 2 – 5 cm, with low-grade dysplasia (LGD), high-grade dysplasia (HGD) or residual BE after endoscopic resection (ER) of a lesion containing HGD or early esophageal adenocarcinoma. Exclusion criteria: previous ER of > 50% circumference, or previous ablation therapy. During the procedure, we aimed to ablate at least 50 – 100% of the BE. Follow-up endoscopy was performed 3 months after treatment. Primary outcome: percentage of endoscopically visible surface regression at 3-months FU, and complications. Secondary outcome: procedure time.
Results:
Thirty patients (median BE C0 (IQR 0 – 1) M3 (IQR 3 – 3,3)) were included. Eighteen patients had undergone ER prior to ablation. The median % BE ablated was 100% (IQR 94 – 100) with a median circumferential extent of 95% (IQR 50 – 100). Median procedure time was 42 minutes (IQR 33 – 60) and median ablation time was 28 minutes (IQR 20 – 45). Median BE surface regression at 3-months FU was 90% (IQR 80 – 99). Multiple residual Barrett's islands were commonly seen. Serious complications occurred in 2/30 patients (7%): 1 perforation and 1 post-procedural bleed, both requiring intervention and hospitalization. 8/30 patients (27%) complained of dysphagia; 4 patients had a stricture requiring intervention. Non-circumferential scarring was seen in 10/27 patients (37%). 18/30 patients (60%) had post-procedural pain or odynophagia, during a median of 5 days (IQR 3 – 10).
Conclusions:
For ablation of Barrett's esophagus, the EndoRotor seems non-inferior to established ablative techniques. However, complication rates seem higher and procedure time longer. Additionally, the difficulty level in operating the device is high, with a high potential for complications in inexperienced hands. For patients with therapy-naive BE, we advise against the use of the EndoRotor.