Through-the-scope Balloon Cryoablation Device for Treating Barrett’s Esophagus

Objective: Ablation of dysplastic Barrett’s has become the mainstay of therapy in many centers. The most common ablation method used is radiofrequency energy, and although effective, it has a number of drawbacks. One of the primary drawbacks is that it cannot be deployed through the endoscope, but is either attached to the endoscope or placed over a guidewire. The CryoBalloon Ablation System (C2 Therapeutics, Inc) is specifically designed to address many of the limitations of current ablation technologies. Some of the benefits may include a shorter and safer procedure, easier deployment, and elimination of sizing procedures.

Description of the technology: Cryoablation is accomplished using a through-the-scope, highly compliant balloon catheter inflated and cooled by an inert refrigerant delivered from a handheld unit. The balloon automatically sizes to the esophageal lumen and applies circumferential freezing.

Preliminary results: A 71 year-old patient scheduled to undergo esophagectomy for esophageal cancer was recruited. The patient received 14 seconds of ablation using the cryoballoon in an area of biopsy-confirmed Barrett’s esophagus, uninvolved by tumor. The patient’s symptoms were monitored post-procedure, and a single dose of oral pain medication was required at home for minimal discomfort. He suffered no complications from the ablation.

The patient underwent esophagectomy on post-ablation day 4. After resection, the ablation site was removed as a full-thickness block and examined histologically. The epithelium of the specimen consisted almost entirely of Barrett’s mucosa with extensive low-grade dysplasia. The center line of the ablation zone showed ablation of approximately 50% of the Barrett’s epithelium, with necrosis of the muscularis mucosa in the areas of ulceration. Up to one-half of the submucosa was necrotic in the area of ablation. Vessels and glands in the lower half of the submucosa remained intact. The muscularis propria remained intact and showed no necrosis.

Conclusions/future directions: Ablation with a novel cryoballoon device results in substantial mucosal injury with minimal pain or impaired swallowing. Major advantages of this device include the ability to standardize the ablation along with the ease of use and quickness of the procedure, since the device goes through the working channel of the endoscope. Future studies will assess the risk of stricture and efficacy for Barrett’s ablation with this device.

 

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