Modified Cap-Assisted Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for the Treatment of Rectal Neuroendocrine Tumors ≤10 mm: A Randomized Noninferiority Trial

Abstract

INTRODUCTION:Although recent guidelines recommend endoscopic resection of rectal neuroendocrine tumors (NET) ≤10 mm, there is no consensus on which endoscopic modality should be performed. We aimed to compare the safety and efficacy of modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic submucosal dissection (ESD) methods for the treatment of rectal NET ≤10 mm.METHODS:A randomized noninferiority trial comparing mEMR-C and ESD was conducted. The primary outcome was the histological complete resection rate; the secondary outcomes included en bloc resection rate, operation time, complications, and so on. Subgroup analyses and follow-up were also performed.RESULTS:Ninety patients were enrolled, and 79 patients with pathologically confirmed rectal NET were finally analyzed, including 38 cases of mEMR-C and 41 cases of ESD. Histological complete resection rate was 97.4% in the mEMR-C group and 92.7% in the ESD group. The noninferiority of mEMR-C compared with that of ESD was confirmed because the absolute difference was 4.7% (2-sided 90% confidence interval, −3.3% to 12.2%; P = 0.616). En bloc resection and successful removal of rectal NET were achieved in all patients. Advantages of mEMR-C over ESD included shorter operation time (8.89 ± 4.58 vs 24.8 ± 9.14 minutes, P < 0.05) and lower hospitalization cost ($2,233.76 ± $717.70 vs $2,987.27 ± $871.81, P < 0.05). Postoperative complications were recorded in 4 patients who received mEMR-C and 2 patients in the ESD group (11.5% vs 4.9%, P = 0.509), which were all well managed using endoscopy. Similar findings were observed when subgroup analysis was performed.DISCUSSION:mEMR-C is noninferior to ESD with a similar complete resection rate. In addition, mEMR-C had shorter procedure duration time and lower hospitalization costs.TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03982264.

Analysis of endoscopic salvage treatment of rectal neuroendocrine tumor; effective utilization of polypectomy

“…Typically, 80-90% of these tumors are less than 1 cm in size, are low grade, exhibit rare metastasis (< 3%), and are diagnosed early in a well-differentiated state con ned to the submucosa [4,12]. Current guidelines from the European Neuroendocrine Oncology Society (ENETS) recommend endoscopic resection for well-differentiated tumors smaller than 10 mm due to their minimal risk of lymphatic and vascular invasion and low malignancy potential [6, 13,14].…”

Efficacy of endoscopic submucosal resection with a ligation device for small rectal neuroendocrine tumor: study protocol of a multicenter open-label randomized control trial (BANDIT trial)

“…Recently, a non-inferiority RCT comparing modi ed EMR-C (EMR-C without injection) and ESD for the treatment of rectal NETs ≤ 10 mm has been reported from China [45]. This single-center study included 38 modi ed EMR-C and 41 ESD cases.…”

A novel cap-assisted endoscopic resection device for resection of a rectal lesion in an in vitro pig model

“…In a previous study, we proved that modified cap-assisted endoscopic mucosal resection (mEMR-C) is non-inferior to endoscopic submucosal dissection (ESD) for rectal neuroendocrine tumors smaller than 10 mm with a similar complete resection rate. In addition, mEMR-C had a shorter procedure duration time and lower hospitalization costs 1 . However, a snare needs to be precisely placed into the inner groove of the cap during the mEMR-C procedure, which is time-consuming and difficult for an inexperienced doctor.…”