Prospective study of endoscopic focal cryoballoon ablation for esophageal squamous cell neoplasia in China

Abstract

Esophageal squamous cell neoplasia (ESCN) has a significant risk for progression to cancer. Current treatment options, endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), have their limitations. The cryoballoon focal ablation system (CbFAS) is a novel endoscopic ablation therapy device. We aimed to assess the safety, tolerability and efficacy of CbFAS for eradication of ESCN. In this single-center prospective trial in China, patients with one flat unstained lesion (USL) on Lugol’s chromoendoscopy which contained moderate or high-grade intraepithelial neoplasia (MGIN/HGIN) were enrolled. CbFAS was performed, using side-by-side applications of 10 seconds, at 3 month intervals until a complete response was established. The response at 12 month was the primary trial endpoint. Safety phone calls were performed at 2, 7 and 30 days after the initial CbFAS. We enrolled 80 patients (59 MGIN, 21 HGIN) with a median USL length of 3 (IQR 3–4) cm. 79 received treatment, with a median 5 (IQR 4–7) side-by-side applications per patient over a median 8 (IQR 5–10) minutes. After a single treatment, 70/78 patients (90%) exhibited CR, and 1 was lost to follow-up. The other 8 with persisting USLs were retreated, and all achieved CR after this second treatment. At 12 months after the initial CbFAS, 76/78 patients (97%) exhibited CR and 2 (3%) had recurrent MGIN. No strictures or serious adverse events occurred. Four patients developed self-limiting mucosal lacerations upon balloon inflation. The post-procedure median pain score was 1 (IQR 0–2) out of 10 at day 2, and 0 (0–0) at days 7 and 30. The results suggest that the cryoballoon focal ablation system is safe, well-tolerated, and effective in inducing endoscopic and histological remission in patients with esophageal squamous cell neoplasia of limited size.