Efficacy and safety of radiofrequency ablation of Barrett’s esophagus in the absence of reimbursement: a multicenter prospective Belgian registry

Abstract

Background Radiofrequency ablation (RFA), combined with endoscopic resection, can be used as a primary treatment for low grade dysplasia, high grade dysplasia, and early esophageal adenocarcinoma (EAC) in Barrett’s esophagus (BE). The aim of the Belgian RFA registry is to capture the real-life outcome of endoscopic therapy for BE with RFA and to assess efficacy and safety outside study protocols, in the absence of reimbursement.

Patients and methods Between February 2008 and January 2017, data from 7 different expert centers were prospectively collected in the registry. Efficacy outcomes included complete remission of intestinal metaplasia (CR-IM), complete remission of dysplasia (CR-D), and durability of remission. Safety outcomes included immediate and late adverse events.

Results 684 RFA procedures in 342 different patients were registered. Of these, 295 patients were included in the efficacy analysis, with CR-IM achieved in 88 % and CR-D in 93 %, in per-protocol analysis; corresponding rates in intention-to-treat analysis were 82 % and 87 %, respectively. Sustained remission was seen in 65 % with a median (interquartile range) follow-up of 25 (12 – 47) months. No risk factors for recurrent disease were identified. Immediate complications occurred in 4 % of all procedures and 6 % of all patients, whereas late complications occurred in 9 % of all procedures and in 20 % of all patients.

Conclusions Data from the Belgian registry confirm that RFA in combination with endoscopic resection is an efficient treatment for BE with dysplasia or early EAC. In the absence of reimbursement, more rescue treatments are used, not compromising outcome. Since there is recurrent disease after CR-IM in 35 %, surveillance endoscopy remains necessary.

• References

• 1 Shaheen NJ, Falk GW, Iyer PG. et al. ACG Clinical Guideline: diagnosis and management of Barrett’s esophagus. Am J Gastroenterol 2016; 111: 30-50
• 2 Weusten B, Bisschops R, Coron E. et al. Endoscopic management of Barrett’s esophagus: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy 2017; 49: 191-198
• 3 Fitzgerald RC, di Pietro M, Ragunath K. et al. British Society of Gastroenterology guidelines on the diagnosis and management of Barrett’s oesophagus. Gut 2014; 63: 7-42
• 4 Chak A, Lee T, Kinnard MF. et al. Familial aggregation of Barrett’s oesophagus, oesophageal adenocarcinoma, and oesophagogastric junctional adenocarcinoma in Caucasian adults. Gut 2002; 51: 323-328
• 5 Desai TK, Krishnan K, Samala N. et al. The incidence of oesophageal adenocarcinoma in non-dysplastic Barrett’s oesophagus: a meta-analysis. Gut 2012; 61: 970-976
• 6 Hamilton SR, Smith RRL, Cameron JL. Prevalence and characteristics of Barrett esophagus in patients with adenocarcinoma of the esophagus or esophagogastric junction. Hum Pathol 1988; 19: 942-948
• 7 Thompson JJ, Zinsser KR, Enterline HT. Barrett’s metaplasia and adenocarcinoma of the esophagus and gastroesophageal junction. Hum Pathol 1983; 14: 42-61
• 8 Spechler SJ. Dysplasia in Barrett’s esophagus: limitations of current management strategies. Am J Gastroenterol 2005; 100: 927-935
• 9 Williams VA, Watson TJ, Herbella FA. et al. Esophagectomy for high grade dysplasia is safe, curative, and results in good alimentary outcome. J Gastrointest Surg 2007; 11: 1589-1597
• 10 Nasr JY, Schoen RE. Prevalence of adenocarcinoma at esophagectomy for Barrett’s esophagus with high grade dysplasia. J Gastrointest Oncol 2011; 2: 34-38
• 11 Oliphant Z, Snow A, Knight H. et al. Endoscopic resection with or without mucosal ablation of high grade dysplasia and early oesophageal adenocarcinoma – long term follow up from a regional UK centre. Int J Surg 2014; 12: 1148-1150
• 12 May A, Gossner L, Pech O. et al. Local endoscopic therapy for intraepithelial high-grade neoplasia and early adenocarcinoma in Barrett’s oesophagus: acute-phase and intermediate results of a new treatment approach. Eur J Gastroenterol Hepatol 2002; 14: 1085-1091
• 13 Ell C, May A, Pech O. et al. Curative endoscopic resection of early esophageal adenocarcinomas (Barrett’s cancer). Gastrointest Endosc 2007; 65: 3-10
• 14 Force SD, Miller DL. Esophageal radiofrequency ablation for the treatment of intestinal metaplasia, low grade dysplasia, and high grade dysplasia. Semin Thorac Cardiovasc Surg 2008; 20: 305-309
• 15 Gaddam S, Sharma P. Advances in endoscopic diagnosis and treatment of Barrett’s esophagus. J Dig Dis 2010; 11: 323-333
• 16 Phoa KN, van Vilsteren FGI, Weusten BLAM. et al. Radiofrequency ablation vs endoscopic surveillance for patients with Barrett esophagus and low-grade dysplasia. J Am Med Assoc 2014; 311: 1209-1217
• 17 Phoa KN, Pouw RE, Bisschops R. et al. Multimodality endoscopic eradication for neoplastic Barrett oesophagus: results of an European multicentre study (EURO-II). Gut 2016; 65: 555-562
• 18 Cotton CC, Duits LC, Wolf WA. et al. Spatial predisposition of dysplasia in Barrett’s esophagus segments: a pooled analysis of the SURF and AIM dysplasia trials. Am J Gastroenterol 2015; 110: 1412-1419
• 19 Haidry RJ, Dunn JM, Butt MA. et al. Radiofrequency ablation and endoscopic mucosal resection for dysplastic Barrett’s esophagus and early esophageal adenocarcinoma: Outcomes of the UK National Halo RFA registry. Gastroenterology 2013; 145: 87-95
• 20 Ganz RA, Overholt BF, Sharma VK. et al. Circumferential ablation of Barrett’s esophagus that contains high-grade dysplasia: a U.S. multicenter registry. Gastrointest Endosc 2008; 68: 35-40
• 21 Phoa KN, Pouw RE, Van Vilsteren FGI. et al. Remission of Barrett’s esophagus with early neoplasia 5 years after radiofrequency ablation with endoscopic resection: a Netherlands cohort study. Gastroenterology 2013; 145: 96-104
• 22 Haidry RJ, Butt MA, Dunn JM. et al. Improvement over time in outcomes for patients undergoing endoscopic therapy for Barrett’s oesophagus-related neoplasia: 6-year experience from the first 500 patients treated in the UK patient registry. Gut 2015; 64: 1192-1199
• 23 Manner H, Pech O, Heldmann Y. et al. The frequency of lymph node metastasis in early-stage adenocarcinoma of the esophagus with incipient submucosal invasion (pT1b sm1) depending on histological risk patterns. Surg Endosc 2015; 29: 1888-1896
• 24 Levine DS, Blount PL, Rudolph RE. et al. Safety of a systematic endoscopic biopsy protocol in patients with Barrett’s esophagus. Am J Gastroenterol 2000; 95: 1152-1157
• 25 Mandal RV, Forcione DG, Brugge WR. et al. Effect of tumor characteristics and duplication of the muscularis mucosae on the endoscopic staging of superficial barrett esophagus-related neoplasia. Am J Surg Pathol 2009; 33: 620-625
• 26 Sharma P, Dent J, Armstrong D. et al. The development and validation of an endoscopic grading system for Barrett’s esophagus: The Prague C & M criteria. Gastroenterology 2006; 131: 1392-1399
• 27 Cotton CC, Wolf WA, Overholt BF. et al. Late recurrence of Barrett’s esophagus after complete eradication of intestinal metaplasia is rare: final report from Ablation in Intestinal Metaplasia Containing Dysplasia trial. Gastroenterology 2017; 153: 681-688
• 28 Agoston AT, Dulai PS, Strauss AC. et al. Predictors of durable treatment response after radiofrequency ablation for Barrett’s esophagus associated intramucosal adenocarcinoma. Am J Surg Pathol 2016; 40: 554-562