A prospective pilot trial of ablation of Barrett’s esophagus with low-grade dysplasia using stepwise circumferential and focal ablation (HALO system)

Background and study aims: Yearly surveillance endoscopy is carried out for Barrett’s esophagus with low-grade dysplasia (LGD) so that progression to high-grade dysplasia and adenocarcinoma can be detected at the earliest stage. The aim of the study was to assess the long-term safety and effectiveness of circumferential ablation followed by focal ablation (HALO system) for eliminating Barrett’s esophagus and LGD.

Patients and methods: Patients with 2 - 6 cm of Barrett’s esophagus with histology demonstrating LGD on their last two sequential endoscopies over the previous 2 years and confirmed by two pathologists were enrolled in this prospective, single-center trial. Circumferential ablation was carried out at baseline and at 4 months (if residual Barrett’s esophagus present). Endoscopy with 4-quadrant biopsies every 1 cm was performed at 1, 3, 6, 12, and 24 months. After 1 year, focal ablation was applied to any visible Barrett’s esophagus or irregularity of the squamocolumnar junction. Patients received lansoprazole 30 mg bid. Complete responses for dysplasia (CR-dysplasia) and intestinal metaplasia (CR-IM) at 2-year follow-up, with complete response defined as “all biopsies negative for dysplasia or intestinal metaplasia” were the main outcomes.

Results: Ten patients (nine men, mean age 66.9 years, range 48 - 79) with confirmed LGD (median 4.4 cm, range 3 - 6) underwent circumferential ablation with focal ablation after 1 year as necessary. At 2 years, CR-dysplasia was 100 % and CR-IM was 90 %. There were no strictures or buried intestinal metaplasia at follow-up.

Conclusion: A stepwise regimen of circumferential ablation followed by focal ablation appears to eradicate intestinal metaplasia (90 % CR-IM) and dysplasia (100 % CR-dysplasia) at 2-year follow-up in this trial, without stricture formation or buried intestinal metaplasia.

References

• 1 Shaheen N, Ransohoff D R. Gastroesophageal reflux, Barrett’s esophagus and esophageal cancer.  JAMA. 2002;  287 1972-1981
• 2 Reid B J. Barrett’s esophagus and adenocarcinoma.  Gastroenterol Clin North Am. 1991;  20 817-834
• 3 Peters J H, Hagen J A, DeMeester S R. Barrett’s esophagus.  J Gastrointest Surg. 2004;  8 1-17
• 4 Sampliner R E. Updated guidelines for the diagnosis, surveillance, and therapy of Barrett’s esophagus.  Am J Gastroenterol. 2002;  97 1888-1895
• 5 Sharma P, Falk G W, Weston A P. et al . Dysplasia and cancer in a large multicenter cohort of patients with Barrett’s esophagus.  Clin Gastroenterol Hepatol. 2006;  4 566-572
• 6 Odze R D. Diagnosis and grading of dysplasia in Barrett’s oesophagus.  J Clin Pathol. 2006;  59 1029-1038
• 7 Sharma P. Low-grade dysplasia in Barrett’s esophagus.  Gastroenterology. 2004;  127 1233-1238
• 8 Sharma P, McQuaid K, Dent J. et al . A critical review of the diagnosis and management of Barrett’s esophagus - The AGA Chicago workshop.  Gastroenterology. 2004;  127 310-330
• 9 Sharma V K, Wang K K, Overholt B F. et al . Balloon-based, circumferential, endoscopic radiofrequency ablation of Barrett’s esophagus: 1-year follow-up of 100 patients.  Gastrointest Endosc. 2007;  65 185-195
• 10 Ganz R A, Utley D S, Stern R A. et al . Complete ablation of esophageal epithelium with a balloon-based bipolar electrode: a phased evaluation in the porcine and in the human esophagus.  Gastrointest Endosc. 2004;  60 1002-1010
• 11 Dunkin B J, Martinez J, Bejarano P A. et al . Thin-layer ablation of human esophageal epithelium using a bipolar radiofrequency balloon device (BÂRRX).  Surg Endosc. 2006;  20 125-130
• 12 Wolfsen H C, Utley D S, Peters J H. In: Yeo CJ, Dempsey DT, Klein AS et al. (eds). Shackelford’s surgery of the alimentary tract. 6th edn. Philadelphia; Saunders Elsevier 2007: 365-373
• 13 Smith C D, Bejarano P A, Melvin W S. et al . Endoscopic ablation of intestinal metaplasia containing high-grade dysplasia in esophagectomy patients using a balloon-based ablation system.  Surg Endosc. 2007;  21 560-569
• 14 Dulai G S, Jensen D M, Cortina G. et al . Randomized trial of argon plasma coagulation vs. multipolar electrocoagulation for ablation of Barrett’s esophagus.  Gastrointest Endosc. 2005;  61 232-240
• 15 Sampliner R E, Faigel D, Fennerty M B. et al . Effective and safe endoscopic reversal of nondysplastic Barrett’s esophagus with thermal electrocoagulation combined with high-dose acid inhibition: a multicenter study.  Gastrointest Endosc. 2001;  53 554-558
• 16 Johnston M H, Eastone J A, Horwhat J D. et al . Cryoablation of Barrett’s esophagus: a pilot study.  Gastrointest Endosc. 2005;  62 842-848
• 17 Gossner L, May A, Stolte M. et al . KTP laser destruction of dysplasia and early cancer in columnarlined Barrett’s esophagus.  Gastrointest Endosc. 1999;  49 8-12
• 18 Seewald S, Akaraviputh T, Seitz U. et al . Circumferential EMR and complete removal of Barrett’s epithelium: a new approach to management of Barrett’s esophagus containing high-grade intraepithelial neoplasia and intramucosal carcinoma.  Gastrointest Endosc. 2003;  57 854-859
• 19 Overholt B F, Lightdale C J, Wang K K. et al . Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett’s esophagus: international, partially blinded, randomized phase III trial.  Gastrointest Endosc. 2005;  62 488-498
• 20 Shaheen N J, Dulai G S, Ascher B. et al . Effect of a new diagnosis of Barrett’s esophagus on insurance status.  Am J Gastroenterol. 2005;  100 577-580
• 21 Shaheen N J, Green B, Medapalli R K. et al . The perception of cancer risk in patients with prevalent Barrett’s esophagus enrolled in an endoscopic surveillance program.  Gastroenterology. 2005;  129 429-436
• 22 Shaheen N J, Crosby M A, Bozymski E M, Sandler R S. Is there a publication bias in reporting cancer risk in Barrett’s esophagus?.  Gastroenterology. 2000;  119 333-338
• 23 Inadomi J M, Madanick R D, Somsouk M, Shaheen N J. Radiofrequency ablation is more cost-effective than endoscopic surveillance or esophagectomy among patients with Barrett’s esophagus and low-grade dysplasia.  Gastroenterology. 2007;  132 Suppl S1 A-53
• 24 Sharma V K, Wells C, Kim H J. et al . Successful ablation of Barrett esophagus with dysplasia using the HALO ablation system in a prospective cohort.  Am J Gastroenterol. 2007;  102 Suppl 2 S547