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Novel device offers complete response in esophageal squamous cell neoplasia
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A novel endoscopic device known as the cryoballoon focal ablation system helped induce endoscopic and histological remission in patients with esophageal squamous cell neoplasia, a precursor of esophageal cancer.
Jacques J.G.H.M. Bergman, MD, PhD, of the department of gastroenterology and hepatology at Amsterdam UMC in the Netherlands and colleagues wrote that while techniques like endoscopic submucosal dissection and endoscopic mucosal resection are effective, they are both difficult and time consuming.
“Ablation therapy could theoretically offer advantages over [endoscopic mucosal resection] and [endoscopic submucosal dissection] in selected patients. It is a relatively easy and quickprocedure and enables treatment of large, circumferential and multifocal early lesions, for which extensive endoscopic resection would likely result in adverse events.”
Researchers tested the safety, tolerability and efficacy of the cryoballoon focal ablation system (CbFAS, C2 Therapeutics) in a single-center trial in China. They recruited 79 patients with one flat unstained lesion on Lugol chromoendoscopy that contained moderate or high-grade intraepithelial neoplasia.
Clinicians performed CbFAS using side-by-side applications for 10 seconds at 3-month intervals until the patient established a complete response. The primary endpoint of the trial was response at 12 months. Researchers also performed safety phone calls at 2, 7 and 30 days after the initial treatment.
After the first treatment, 70 of 78 patients achieved complete response (90%), while one was lost to follow-up. Physicians retreated the remaining eight patients with persisting lesions, and all of them achieved complete response after the second treatment.
After 12 months, 76 patients exhibited complete response (97%) and two had recurrent moderate-grade intraepithelial neoplasia
Investigators observed no serious adverse events, and the median pain scores were 1 out of 10 at day 2 (interquartile range, 0–2) and 0 at days 7 and 30.
“These early outcomes of cryoballoon ablation for treatment of carefully selected patients with ESCN are very encouraging. To better understand the role of cryoballoon ablation in the management of ESCN, studies of the depth of cryoballoon ablation, longer-term follow-up data on the current patients, additional studies of patients with larger [esophageal squamous cell neoplasia] lesions, and comparative studies with other endoscopic modalities, such as [endoscopic mucosal resection], [endoscopic submucosal dissection] and [radiofrequency ablation], will be necessary.” – by Alex Young
Disclosures: The study was sponsored by C2 Therapeutics.
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