Roos E Pouw1, Esther Klaver1, K Nadine Phoa1, Frederike G van Vilsteren1, Bas L Weusten2, Raf Bisschops3, Erik J Schoon4, Oliver Pech5, Hendrik Manner6, Krish Ragunath7, Jacobo Ortiz Fernández-Sordo7, Grant Fullarton8, Massimiliano Di Pietro9, Wladyslaw Januszewicz9, Dermot O'Toole10, Jacques J Bergman1. 1. Department of Gastroenterology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. 2. Department of Gastroenterology, St Antonius Hospital, Nieuwegein, the Netherlands. 3. Department of Gastroenterology, University Hospital Leuven, Leuven, Belgium. 4. Department of Gastroenterology, Catharina Hospital, Eindhoven, the Netherlands. 5. Department of Gastroenterology, Helios dr. Horst Schmidt Clinics Wiesbaden, Germany. 6. Department of Gastroenterology, Frankfurt Hoechst Hospital, Frankfurt, Germany. 7. Department of Gastroenterology, Queens Medical Center, Nottingham, UK. 8. Department of Surgical Gastroenterology, Glasgow Royal Infirmary, Glasgow, Scotland. 9. Medical Research Council, Cancer Unit, Addenbrookes Hospital, Cambridge, UK. 10. Department of Clinical Medicine and Gastroenterology, St James's Hospital, Dublin, Ireland.
Abstract
BACKGROUND AND AIMS: A prior randomized study (Surveillance versus Radiofrequency Ablation study [SURF study]) demonstrated that radiofrequency ablation (RFA) of Barrett's esophagus (BE) with confirmed low-grade dysplasia (LGD) significantly reduces the risk of esophageal adenocarcinoma. Our aim was to report the long-term outcomes of this study. METHODS: The SURF study randomized BE patients with confirmed LGD to RFA or surveillance. For this retrospective cohort study, all endoscopic and histologic data acquired at the end of the SURF study in May 2013 until December 2017 were collected. The primary outcome was rate of progression to high-grade dysplasia (HGD)/cancer. All 136 patients randomized toRFA (n = 68) or surveillance (n = 68) in the SURF study were included. After closure of the SURF study, 15 surveillance patients underwentRFA based on patient preference and study outcomes. RESULTS: With 40 additional months (interquartile range, 12-51), the total median follow-up from randomization to last endoscopy was 73 months (interquartile range, 46-85). HGD/cancer was diagnosed in 1 patient in the RFA group (1.5%) and in 23 in the surveillance group (33.8%) (P = .000), resulting in an absolute risk reduction of 32.4% (95% confidence interval [CI], 22.4%-44.2%) with a number needed to treat of 3.1 (95% CI, 2.3-4.5). Seventy-five of 83 patients (90%; 95% CI, 82.1%-95.0%) treated with RFA for BE reached complete clearance of BE and dysplasia. BE recurred in 7 of 75 patients (9%; 95% CI, 4.6%-18.0%), mostly minute islands or tongues, and LGD in 3 of 75 (4%; 95% CI, 1.4%-11.1%). CONCLUSIONS:RFA of BE with confirmed LGD significantly reduces the risk of malignant progression, with sustained clearance of BE in 91% and LGD in 96% of patients, after a median follow-up of 73 months. (Clinical trial registration number: NTR1198.).
RCT Entities:
BACKGROUND AND AIMS: A prior randomized study (Surveillance versus Radiofrequency Ablation study [SURF study]) demonstrated that radiofrequency ablation (RFA) of Barrett's esophagus (BE) with confirmed low-grade dysplasia (LGD) significantly reduces the risk of esophageal adenocarcinoma. Our aim was to report the long-term outcomes of this study. METHODS: The SURF study randomized BEpatients with confirmed LGD to RFA or surveillance. For this retrospective cohort study, all endoscopic and histologic data acquired at the end of the SURF study in May 2013 until December 2017 were collected. The primary outcome was rate of progression to high-grade dysplasia (HGD)/cancer. All 136 patients randomized to RFA (n = 68) or surveillance (n = 68) in the SURF study were included. After closure of the SURF study, 15 surveillance patients underwent RFA based on patient preference and study outcomes. RESULTS: With 40 additional months (interquartile range, 12-51), the total median follow-up from randomization to last endoscopy was 73 months (interquartile range, 46-85). HGD/cancer was diagnosed in 1 patient in the RFA group (1.5%) and in 23 in the surveillance group (33.8%) (P = .000), resulting in an absolute risk reduction of 32.4% (95% confidence interval [CI], 22.4%-44.2%) with a number needed to treat of 3.1 (95% CI, 2.3-4.5). Seventy-five of 83 patients (90%; 95% CI, 82.1%-95.0%) treated with RFA for BE reached complete clearance of BE and dysplasia. BE recurred in 7 of 75 patients (9%; 95% CI, 4.6%-18.0%), mostly minute islands or tongues, and LGD in 3 of 75 (4%; 95% CI, 1.4%-11.1%). CONCLUSIONS: RFA of BE with confirmed LGD significantly reduces the risk of malignant progression, with sustained clearance of BE in 91% and LGD in 96% of patients, after a median follow-up of 73 months. (Clinical trial registration number: NTR1198.).
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