Stepwise radical endoscopic resection versus radiofrequency ablation for Barrett's oesophagus with high-grade dysplasia or early cancer: a multicentre randomised trial
- Frederike G I van Vilsteren1,
- Roos E Pouw1,
- Stefan Seewald2,
- Lorenza Alvarez Herrero3,
- Carine M T Sondermeijer1,
- Mike Visser4,
- Fiebo J W ten Kate4,
- Karl C Yu Kim Teng2,
- Nib Soehendra2,
- Thomas Rösch2,
- Bas L A M Weusten3,
- Jacques J G H M Bergman1
- 1Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands
- 2Department of Interdisciplinary Endoscopy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
- 3Department of Gastroenterology, St Antonius Hospital, Nieuwegein, The Netherlands
- 4Department of Pathology, Academic Medical Center, Amsterdam, The Netherlands
- Correspondence to Dr Jacques Bergman, Department of Gastroenterology and Hepatology, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands;
- Revised 5 November 2010
- Accepted 30 November 2010
- Published Online First 5 January 2011
Objective After focal endoscopic resection (ER) of high-grade dysplasia (HGD) or early cancer (EC) in Barrett's oesophagus (BO), eradication of all remaining BO reduces the recurrence risk. The aim of this study was to compare the safety of stepwise radical ER (SRER) versus focal ER followed by radiofrequency ablation (RFA) for complete eradication of BO containing HGD/EC.
Methods A multicentre randomised clinical trial was carried out in three tertiary centres. Patients with BO ≤5 cm containing HGD/EC were randomised to SRER or ER/RFA. Patients in the SRER group underwent piecemeal ER of 50% of BO followed by serial ER. Patients in the ER/RFA group underwent focal ER for visible lesions followed by serial RFA. Follow-up endoscopy with biopsies (four-quadrant/2 cm BO) was performed at 6 and 12 months and then annually. The main outcome measures were: stenosis rate; complications; complete histological response for neoplasia (CR-neoplasia); and complete histological response for intestinal metaplasia (CR-IM).
Results CR-neoplasia was achieved in 25/25 (100%) SRER and in 21/22 (96%) ER/RFA patients. CR-IM was achieved in 23 (92%) SRER and 21 (96%) ER/RFA patients. The stenosis rate was significantly higher in SRER (88%) versus ER/RFA (14%; p<0.001), resulting in more therapeutic sessions in SRER (6 vs 3; p<0.001) due to dilations. After median 24 months follow-up, one SRER patient had recurrence of EC, requiring ER.
Conclusions In patients with BO ≤5 cm containing HGD/EC, SRER and ER/RFA achieved comparably high rates of CR-IM and CR-neoplasia. However, SRER was associated with a higher number of complications and therapeutic sessions. For these patients, a combined endoscopic approach of focal ER followed by RFA may thus be preferred over SRER.
Clinical trial number NTR1337.
- Barrett's oesophagus
- radiofrequency ablation
- endoscopic resection
- endoscopic procedures
Funding BÂRRX Medical, Sunnyvale, CA, USA.
Competing interests Grant support from BÂRRX Medical. JJGHMB received unrestricted grants from Astra Zeneca, Olympus Medical and Cook Medical.
Patient consent Obtained.
Ethics approval This study was conducted with the approval of the Academic Medical Center (Amsterdam, The Netherlands), Sint Antonius Hospital (Nieuwegein, The Netherlands) and University Medical Center Hamburg-Eppendorf (Hamburg, Germany).
Provenance and peer review Not commissioned; externally peer reviewed.