P2212 - Balloon Cryotherapy is Highly Effective in Patients With Poor Response to Radiofrequency Ablation Therapy for Dysplastic Barrett’s Esophagus: Preliminary Results from the NO FEAR-BE Study

Nicholas J.. Shaheen, MD, MPH¹, Marcia Canto, MD², Cary C. Cotton, MD, MPH³, Prasad G. Iyer, MD, MS, FACG⁴, Julian Abrams, MD⁵, Harshit S.. Khara, MD, FACG⁶, Puja Elias, MD⁷, Amitabh Chak, MD⁸, Shervin Shafa, MD⁹, Shajan Peter, MD¹⁰, Nirav Thosani, MD¹¹, Michael S.. Smith, MD, MBA¹², Susan Moist, ¹³, Lindsay Cortright, ¹³, Kacie Walker, ¹³, Julia Kim, ¹³, Carson Jones, ¹³, Arvind Trindade, MD^14
1University of North Carolina at Chapel Hill, Durham, NC; ²Johns Hopkins University School of Medicine, Baltimore, MD; ³University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC; ⁴Mayo Clinic, Phoenix, AZ; ⁵Columbia University, New York, NY; ⁶Geisinger Medical Center, Danville, PA; ⁷Medical University of South Carolina, Charleston, SC; ⁸Digestive Health Institute, University Hospitals Cleveland Medical Center, Cleveland, OH; ⁹MedStar Georgetown University Hospital, Washington, DC; ¹⁰Basil I. Hirschowitz Endoscopic Center of Excellence, The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, AL; ¹¹McGovern Medical School at UTHealth, Houston, TX; ¹²Icahn School of Medicine at Mount Sinai, New York, NY; ¹³University of North Carolina at Chapel Hill, Chapel Hill, NC; ¹⁴Robert Wood Johnson Medical School, Rutgers University, New Brunswick, NJ

Introduction: Radiofrequency ablation (RFA) is effective for the initial endoscopic eradication of Barrett’s esophagus (BE) with dysplasia, but up to a quarter of patients treated with RFA will not achieve complete eradication of intestinal metaplasia (CEIM). Data describing second-line treatments are sparse. We present preliminary results of balloon cryotherapy ablation (CbFAS) as rescue therapy after poor response to RFA.

Methods: Participants who had poor response to RFA, defined as persistent esophageal intestinal metaplasia or dysplasia after ≥3 RFA treatments or after two treatments with less than 50% resolution of baseline BE, were enrolled. Eligible participants received CbFAS every 3 months for up to 12 months or until CEIM was achieved. Participants who achieved CEIM were followed for an additional year. All cases which completed the treatment phase were analyzed. We estimated the cumulative incidence of CEIM, complete eradication of dysplasia (CED), and stricture, and calculated the exact binomial confidence limit for those proportions. A Poisson model of rates of recurrence of intestinal metaplasia and progression with 95% confidence limits was constructed.

Results: Included in this preliminary analysis were 26 of 54 participants that completed the treatment phase (Table). Of these 26 participants, 21 (80.8%, 95% CI 60.6 - 93.4%) achieved CEIM at a mean 216.8 days and 3.2 CbFAS treatments. The same number achieved CED. Of 17 patients with at least one follow-up endoscopy after CEIM, there were 3 recurrences of intestinal metaplasia during a mean 288.0 days of follow-up after CEIM (0.22 per person-year, 95% CI 0.07 - 0.69). There were recurrences with definite dysplasia or progression (0.0%, 95% CI 0.0% - 19.5%). Of 26 participants, 2 (7.7%, 95% CI 0.9 - 25.1%) had a stricture during treatment or follow-up.

Discussion: In patients who were poorly responsive to RFA, CbFAS appears effective and durable in preliminary results. While patients who fail prior treatments are likely less treatment-responsive, CbFAS appeared similarly effective to established first-line treatments in treatment-naïve patients. Recurrence rates were comparable to rates reported in treatment-naïve patients in the first year. However, with only 17 participants in surveillance and < 1 year of follow up data on average, post-CEIM data were limited by statistical uncertainty.



Disclosures:


Nicholas J.. Shaheen, MD, MPH¹, Marcia Canto, MD², Cary C. Cotton, MD, MPH³, Prasad G. Iyer, MD, MS, FACG⁴, Julian Abrams, MD⁵, Harshit S.. Khara, MD, FACG⁶, Puja Elias, MD⁷, Amitabh Chak, MD⁸, Shervin Shafa, MD⁹, Shajan Peter, MD¹⁰, Nirav Thosani, MD¹¹, Michael S.. Smith, MD, MBA¹², Susan Moist, ¹³, Lindsay Cortright, ¹³, Kacie Walker, ¹³, Julia Kim, ¹³, Carson Jones, ¹³, Arvind Trindade, MD¹⁴. P2212 - Balloon Cryotherapy is Highly Effective in Patients With Poor Response to Radiofrequency Ablation Therapy for Dysplastic Barrett’s Esophagus: Preliminary Results from the NO FEAR-BE Study, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.