ESD probably no better than EMR in Barrett’s neoplasia
Thomas Rösch, Hamburg
Gut. 2016 Jan 22. pii: gutjnl-2015-310126. [Epub ahead of print]
|A randomised trial of endoscopic submucosal dissection versus endoscopic mucosal resection for early Barretts`s neoplasia|
|Grischa Terheggen1, Eva Maria Horn2, Michael Vieth3, Helmut Gabbert4, Markus Enderle5, Alexander Neugebauer5, Brigitte Schumacher6, Horst Neuhaus2|
BackgroundFor endoscopic resection of early GI neoplasia, endoscopic submucosal dissection (ESD) achieves higher rates of complete resection (R0) than endoscopic mucosal resection (EMR). However, ESD is technically more difficult and evidence from randomized trial is missing.
ObjectiveWe compared the efficacy and safety of ESD and EMR in patients with neoplastic Barrett’s oesophagus (BO). Design BO patients with a focal lesion of high-grade intraepithelial neoplasia (HGIN) or early adenocarcinoma (EAC) ≤3 cm were randomized to either ESD or EMR. Primary outcome was R0 resection; secondary outcomes were complete remission from neoplasia, recurrences and adverse events (AEs).
ResultsThere were no significant differences in patient and lesion characteristics between the groups randomised to ESD (n=20) or EMR (n=20). Histology of the resected specimen showed HGIN or EAC in all but six cases. Although R0 resection defined as margins free of HGIN/EAC was achieved more frequently with ESD (10/17 vs 2/17, p=0.01), there was no difference in complete remission from neoplasia at 3 months (ESD 15/16 vs EMR 16/17, p=1.0). During a mean follow-up period of 23.1±6.4 months, recurrent EAC was observed in one case in the ESD group. Elective surgery was performed in four and three cases after ESD and EMR, respectively (p=1.0). Two severe AEs were recorded for ESD and none for EMR ( p=0.49).
ConclusionsIn terms of need for surgery, neoplasia remission and recurrence, ESD and EMR are both highly effective for endoscopic resection of early BO neoplasia. ESD achieves a higher R0 resection rate, but for most BO patients this bears little clinical relevance. ESD is, however, more time consuming and may cause severe AE.
What you need to knowConsiderable debate is currently taking place among therapeutic endoscopists regarding the best method of resecting early carcinomas, particularly in the upper gastrointestinal tract — whereas the corresponding debate regarding the colorectum is somewhat more difficult, due to the biological differences. The methods that were compared here were endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD). In the latter procedure, an effort is made to resect the lesion en bloc, while EMR has to make do with piecemeal ablation of the tumor, particularly with lesions larger than 2 cm. In general, the discussion is not based on high-grade evidence, as there has not been a single no randomized study on EMR versus ESD, even though in Japan and other East Asian countries thousands of procedures are carried out every year. The impression is given by so-called meta-analyses of retrospective studies that ESD is superior to EMR with regard to the rates of complete R0 resection and the recurrence rate, although it is associated with a significantly larger number of complications. “Meta-analyses” of this type have been carried out for EMR versus ESD and for ESD alone with squamous cell carcinoma of the esophagus , gastric carcinoma [2–4], and colorectal neoplasia [5,6]. This study by the Düsseldorf group, the first randomized study on ESD versus EMR, is therefore very welcome, although it is a small one and only surrogate parameters were used for the outcome. Forty patients with visible focal Barrett’s neoplasia with high-grade dysplasia or early carcinoma were randomly assigned to undergo focal resection of the lesion either with EMR or ESD. Subsequently, the residual Barrett’s segment was eradicated using radiofrequency ablation. The primary outcome was R0 resection, and the large differences that were expected here permitted the relatively small number of patients in the sample size calculation. The study was therefore not sufficiently powered for the secondary outcome — i.e., complete remission of neoplasia and/or Barrett’s esophagus — as the number of cases was too small. Endoscopic follow-up examinations were carried out after 3, 6, 9, and 12 months; the mean follow-up period was 23 months in both groups. Not unexpectedly, the results show that ESD is superior with regard to complete and R0 resection, although the findings were less spectacular than expected. However, the follow-up results did not differ with regard to the outcome , with only one local recurrence developing — which was in the ESD group. Details are shown in the following table. Three patients were excluded from each group, as the histological findings showed a normal Barrett’s segment or only low-grade dysplasia despite initial biopsy diagnoses in accordance with the inclusion criteria (see above).
|Complete R0 resection||10/17||2/17||0.01|
|Procedure duration||54 min||22 min||0.00002|
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