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Stepwise radical endoscopic resection versus radiofrequency ablation for Barrett's oesophagus with high-grade dysplasia or early cancer: a multicentre randomised trial.
Gut. 2011 Jun; 60(6):765-73.Gut

Abstract

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.

Authors+Show Affiliations

Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21209124

Citation

van Vilsteren, Frederike G I., et al. "Stepwise Radical Endoscopic Resection Versus Radiofrequency Ablation for Barrett's Oesophagus With High-grade Dysplasia or Early Cancer: a Multicentre Randomised Trial." Gut, vol. 60, no. 6, 2011, pp. 765-73.
van Vilsteren FG, Pouw RE, Seewald S, et al. Stepwise radical endoscopic resection versus radiofrequency ablation for Barrett's oesophagus with high-grade dysplasia or early cancer: a multicentre randomised trial. Gut. 2011;60(6):765-73.
van Vilsteren, F. G., Pouw, R. E., Seewald, S., Alvarez Herrero, L., Sondermeijer, C. M., Visser, M., Ten Kate, F. J., Yu Kim Teng, K. C., Soehendra, N., Rösch, T., Weusten, B. L., & Bergman, J. J. (2011). Stepwise radical endoscopic resection versus radiofrequency ablation for Barrett's oesophagus with high-grade dysplasia or early cancer: a multicentre randomised trial. Gut, 60(6), 765-73. https://doi.org/10.1136/gut.2010.229310
van Vilsteren FG, et al. Stepwise Radical Endoscopic Resection Versus Radiofrequency Ablation for Barrett's Oesophagus With High-grade Dysplasia or Early Cancer: a Multicentre Randomised Trial. Gut. 2011;60(6):765-73. PubMed PMID: 21209124.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Stepwise radical endoscopic resection versus radiofrequency ablation for Barrett's oesophagus with high-grade dysplasia or early cancer: a multicentre randomised trial. AU - van Vilsteren,Frederike G I, AU - Pouw,Roos E, AU - Seewald,Stefan, AU - Alvarez Herrero,Lorenza, AU - Sondermeijer,Carine M T, AU - Visser,Mike, AU - Ten Kate,Fiebo J W, AU - Yu Kim Teng,Karl C, AU - Soehendra,Nib, AU - Rösch,Thomas, AU - Weusten,Bas L A M, AU - Bergman,Jacques J G H M, Y1 - 2011/01/05/ PY - 2011/1/7/entrez PY - 2011/1/7/pubmed PY - 2011/7/16/medline SP - 765 EP - 73 JF - Gut JO - Gut VL - 60 IS - 6 N2 - 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. SN - 1468-3288 UR - https://www.unboundmedicine.com/medline/citation/21209124/Stepwise_radical_endoscopic_resection_versus_radiofrequency_ablation_for_Barrett's_oesophagus_with_high_grade_dysplasia_or_early_cancer:_a_multicentre_randomised_trial_ L2 - http://gut.bmj.com/cgi/pmidlookup?view=long&amp;pmid=21209124 DB - PRIME DP - Unbound Medicine ER -