Cryoballoon ablation safe, effective for neoplastic Barrett’s esophagus
Cryoballoon ablation was safe and effective in patients with neoplastic Barrett’s esophagus, according to a study published in the American Journal of Gastroenterology.
“[In] this large multicenter single-arm prospective clinical trial of [cryoballoon (CBA)] in patients with previously unablated neoplastic BE, with or without previous [endoscopic mucosal resection], CBA-induced eradication of dysplasia in over three-fourths of patients, with good safety and excellent patient tolerability,” Marcia Irene Canto, MD, MHS, from the department of medicine at Johns Hopkins Medical Institutions in Baltimore, and colleagues wrote. “More research using the newer wide area CBA system in a larger population will better define its efficacy and clinical utility.”
Canto and colleagues performed a prospective clinical of 120 patients with BE with intramucosal adenocarcinoma, high-grade dysplasia or low-grade dysplasia from 11 academic and community centers. All visible columnar mucosa in patients was treated with a nitrous oxide cryoballoon focal ablation system in up to five sessions. Complete eradication of all dysplasia (CE-D) and intestinal metaplasia (CE-IM) at 1 year served as the study endpoints.
“Patients with symptomatic pre-existing strictures or visible BE lesions had dilation or endoscopic mucosal resection (EMR), respectively, before enrollment,” Canto and colleagues wrote.
Results showed the CE-D rate in the intention-to-treat analysis was 76% and the CE-IM rate was 72%. Further, the CE-D rate in the per-protocol analysis was 97% and the CE-IM rate was 91%. Investigators reported post-ablation pain was mild and short lived. Fifteen patients needed dilation because they developed strictures.
“One patient (0.8%) with HGD progressed to [intramucosal adenocarcinoma], which was successfully treated with EMR,” the researchers wrote. Another patient (0.8%) developed gastrointestinal bleeding associated with clopidogrel use. One patient (0.8%) had buried BE with HGD in one biopsy, not confirmed by subsequent EMR.”