A randomised trial of endoscopic submucosal dissection versus endoscopic mucosal resection for early Barrett's neoplasia

Abstract

Background: For 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 randomised trial is missing.

Objective: We 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 randomised to either ESD or EMR. Primary outcome was R0 resection; secondary outcomes were complete remission from neoplasia, recurrences and adverse events (AEs).

Results: There 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).

Conclusions: In 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.

Trial registration number: NCT1871636.

Trial registration: ClinicalTrials.gov NCT01871636.

Keywords: BARRETT’S OESOPHAGUS; ENDOSCOPIC PROCEDURES; ENDOSCOPY.

Figure 1

(A) Early Barrett adenocarcinoma, type 0–IIa and IIc (between yellow markers). (B) Endoscopic mucosal resection (EMR) showing part of the lesion including coagulation markers in the resection cap. (C) Area after complete resection of the lesion by piecemeal EMR. (D) Histology of one of the resected specimen showing mucosal adenocarcinoma pT1a (m1), L0, V0, tumour cell dissociation=0, pNX, R1 (HM1, VM0) G1 (blue bar: extension of AC, blue circle: deepest vertical tumour margin, yellow bar: upper muscularis mucosae, orange bar: lower muscularis mucosae).

Figure 2

(A) Early Barrett adenocarcinoma, type 0–IIa and IIc (between yellow markers). (B) Endoscopic submucosal dissection (ESD) with circumferential incision of the mucosa at the periphery of coagulation markers with the HybridKnife. (C) Dissection of the submucosal layer by injection of saline solution with indigocarmine and subsequent cutting. (D) Area after complete en-bloc resection of the lesion by ESD. (E) Histology of the resected specimen showing mucosal adenocarcinoma pT1a (m2), L0, V0, tumour cell dissociation (TCD)=0, pNX, R0 (HM0, VM0) G2 (bar: upper layer of muscular mucosa; arrow: tumour cell complex invading the upper layer of the muscularis mucosae).