K Nadine Phoa1, Roos E Pouw1, Raf Bisschops2, Oliver Pech3, Krish Ragunath4, Bas L A M Weusten5, Brigitte Schumacher6, Bjorn Rembacken7, Alexander Meining8, Helmut Messmann9, Erik J Schoon10, Liebwin Gossner11, Jayan Mannath4, C A Seldenrijk12, Mike Visser13, Toni Lerut2, Stefan Seewald14, Fiebo J ten Kate13, Christian Ell3, Horst Neuhaus6, Jacques J G H M Bergman1. 1. Department of Gastroenterology and Hepatology, Academic Medical Centre-University of Amsterdam, Amsterdam, the Netherlands. 2. Department of Gastroenterology, University Hospitals Leuven, Leuven, Vlaams Brabant, Belgium. 3. Department of Internal Medicine II, Dr. Horst-Schmidt-Kliniken, Wiesbaden, Germany. 4. Department of Gastroenterology, Queens Medical Centre, Nottingham, UK. 5. Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, the Netherlands. 6. Department of Gastroenterology, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany. 7. Department of Gastroenterology, The General Infirmary at Leeds, Leeds, UK. 8. Department of Gastroenterology, Klinikum rechts der Isar, Munich, Germany. 9. Department of Gastroenterology, Augsburg Hospital, Augsburg, Germany. 10. Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, Netherlands. 11. Department of Internal Medicine II, Karlsruhe Hospital, Karlsruhe, Germany. 12. Department of Pathology, St Antonius Hospital, Nieuwegein, the Netherlands. 13. Department of Pathology, Academic Medical Centre-University of Amsterdam, Amsterdam, the Netherlands. 14. Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Abstract
OBJECTIVE: Focal endoscopic resection (ER) followed by radiofrequency ablation (RFA) safely and effectively eradicates Barrett's oesophagus (BO) containing high-grade dysplasia (HGD) and/or early cancer (EC) in smaller studies with limited follow-up. Herein, we report long-term outcomes of combined ER and RFA for BO (HGD and/or EC) from a single-arm multicentre interventional study. DESIGN: In 13 European centres, patients with BO ≤ 12 cm with HGD and/or EC on 2 separate endoscopies were eligible for inclusion. Visible lesions (<2 cm length; <50% circumference) were removed with ER, followed by serial RFA every 3 months (max 5 sessions). Follow-up endoscopy was scheduled at 6 months after the first negative post-treatment endoscopic control and annually thereafter. OUTCOMES: complete eradication of neoplasia (CE-neo) and intestinal metaplasia (CE-IM); durability of CE-neo and CE-IM (once achieved) during follow-up. Biopsy and resection specimens underwent centralised pathology review. RESULTS: 132 patients with median BO length C3M6 were included. After entry-ER in 119 patients (90%) and a median of 3 RFA (IQR 3-4) treatments, CE-neo was achieved in 121/132 (92%) and CE-IM in 115/132 patients (87%), per intention-to-treat analysis. Per-protocol analysis, CE-neo and CE-IM were achieved in 98% and 93%, respectively. After a median of 27 months following the first negative post-treatment endoscopic control, neoplasia and IM recurred in 4% and 8%, respectively. Mild-to-moderate adverse events occurred in 25 patients (19%); all managed conservatively or endoscopically. CONCLUSIONS: In patients with early Barrett's neoplasia, intensive multimodality endotherapy consisting of ER combined with RFA is safe and highly effective, and the treatment effect appears to be durable during mid-term follow-up. TRIAL REGISTRATION NUMBER: NTR 1211, http://www.trialregister.nl. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
OBJECTIVE: Focal endoscopic resection (ER) followed by radiofrequency ablation (RFA) safely and effectively eradicates Barrett's oesophagus (BO) containing high-grade dysplasia (HGD) and/or early cancer (EC) in smaller studies with limited follow-up. Herein, we report long-term outcomes of combined ER and RFA for BO (HGD and/or EC) from a single-arm multicentre interventional study. DESIGN: In 13 European centres, patients with BO ≤ 12 cm with HGD and/or EC on 2 separate endoscopies were eligible for inclusion. Visible lesions (<2 cm length; <50% circumference) were removed with ER, followed by serial RFA every 3 months (max 5 sessions). Follow-up endoscopy was scheduled at 6 months after the first negative post-treatment endoscopic control and annually thereafter. OUTCOMES: complete eradication of neoplasia (CE-neo) and intestinal metaplasia (CE-IM); durability of CE-neo and CE-IM (once achieved) during follow-up. Biopsy and resection specimens underwent centralised pathology review. RESULTS: 132 patients with median BO length C3M6 were included. After entry-ER in 119 patients (90%) and a median of 3 RFA (IQR 3-4) treatments, CE-neo was achieved in 121/132 (92%) and CE-IM in 115/132 patients (87%), per intention-to-treat analysis. Per-protocol analysis, CE-neo and CE-IM were achieved in 98% and 93%, respectively. After a median of 27 months following the first negative post-treatment endoscopic control, neoplasia and IM recurred in 4% and 8%, respectively. Mild-to-moderate adverse events occurred in 25 patients (19%); all managed conservatively or endoscopically. CONCLUSIONS: In patients with early Barrett's neoplasia, intensive multimodality endotherapy consisting of ER combined with RFA is safe and highly effective, and the treatment effect appears to be durable during mid-term follow-up. TRIAL REGISTRATION NUMBER: NTR 1211, http://www.trialregister.nl. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Entities:
Keywords:
BARRETT'S CARCINOMA; ENDOSCOPIC PROCEDURES; OESOPHAGEAL CANCER
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