CryoBalloon Ablation for Treatment of Duodenal Adenomas

Duodenal Adenomas, Familial Adenomatous Polyposis

This multicenter prospective non-randomized interventional study (clinical trial) that will assess the safety and efficacy of cryoballoon ablation treatment using the C2 Cryoballoon device (Pentax Medical Corporation) as an alternative primary treatment modality for sporadic and familial nonampullary nonpolypoid (flat) duodenal adenomas.

Duodenal adenomas are precursors to adenocarcinoma. Treatment with endoscopic polypectomy is technically challenging problematic and associated with a high rate of complication - overall 26%, with bleeding 22-40%, higher with larger polyps. Surgery to remove these benign polyps would be a Whipple operation, which has a high morbidity and 1-4% mortality rate. Medical therapies like celecoxib decrease the number of polyps but do not prevent cancer. This multicenter prospective cohort study will assess the safety and efficacy of cryoablation treatment as an alternative primary treatment modality for sporadic and familial nonampullary nonpolypoid (flat) duodenal adenomas Prospective studies have demonstrated the safety and efficacy of nitrous oxide focal cryoballoon ablation for complete eradication of Barrett's esophagus (including a clinical trial published by the Principal Investigator), which is intestinal metaplasia, which is histologically similar to normal duodenal mucosa. When inflated, the cryoballoon flattens the duodenal folds allowing improved visibility of the duodenal lesions. The focal ablation allows precise targeting and avoidance of the ampulla to minimize pancreatitis risk. Two cases at Johns Hopkins Hospital have been treated successfully and safely using cryogen dose of 10 seconds. The procedures were easy and short, with excellent views of the lesion with balloon inflation and high definition endoscope. No major adverse events, pain requiring treatment, or bleeding were noted. Minor adverse events included transient abdominal bloating lasting for \< 3 days in 1 patient. In one patient with sporadic laterally spreading large Paris 2A polyp who declined standard treatments, complete eradication was achieved with 2 ablation sessions. In the other patient with familial adenomatous polyposis (FAP) who had 2 hospitalizations for post-polypectomy bleeding after duodenal EMR, complete eradication was noted after 1 treatment of 3 Paris 2A and 2B adjacent polyps. Follow-up of these two patients shows no recurrence \> 1 year and at the most recent follow-up procedures. Clinical and endoscopic surveillance continues. In addition, another physician at the University of Texas Health Science Center at San Antonio (UTHSCSA) reported another two patients with duodenal adenomas in her practice treated successfully with cryoballoon ablation without complications. Two other collaborating physicians at Memorial Hermann Texas Medical Center in Houston, Texas, and Geisinger Medical Center in Pennsylvania have also reported favorable response of these challenging neoplasms to endoscopic cryoballoon ablation. The group is currently preparing a case series report and a separate Institutional Review Board application is being submitted. This study may impact on the management of patients with duodenal adenomas by demonstrating the potential for safe and effective non-operative eradication using cryoballoon ablation. The safety profile of endoscopic cryoballoon ablation is likely to be better than endoscopic resection based on a large clinical and research experience in Barrett's esophagus patients (\>250) and small clinical experience in duodenal adenoma patients, with \<=5% bleeding, no perforation, and transient, mild post-treatment discomfort.

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United States