Dataset Information

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.

SUBMITTER: Gao X

PROVIDER: S-EPMC10508268 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

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

Gao Xuelian X Huang Shaohui S Wang Yusi Y Peng Qun Q Li Weixin W Zou Yingying Y Han Zelong Z Cai Jianqun J Luo Yuchen Y Ye Yaping Y Li Aimin A Bai Yang Y Chen Ye Y Liu Side S Li Yue Y

The American journal of gastroenterology 20220823 12

<h4>Introduction</h4>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.<h4>Methods</h4>A randomized noninferiority trial comparing mEMR-C and ESD was conducted. The primary outc ...[more]

PMID: 36455222

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Project description:BACKGROUNDThe incidence of rectal neuroendocrine tumors (NETs) is rapidly increasing because of the frequent use of endoscopic screening for colorectal cancers. However, the clinical outcomes of endoscopic resection for rectal NETs are still unclear. The aim of this study was to assess the rates of histologically complete resection (H-CR) and recurrence after endoscopic mucosal resection (EMR) for rectal NETs.METHODSA retrospective analysis was performed on patients who underwent EMR for rectal NETs between January 2002 and March 2015 at Seoul National University Hospital. Primary outcomes were H-CR and recurrence rates after endoscopic resection. H-CR was defined as the absence of tumor invasion in the lateral and deep margins of resected specimens.RESULTSAmong 277 patients, 243 (88%) were treated with conventional EMR, 23 (8%) with EMR using a dual-channel endoscope, and 11 (4%) with EMR after precutting. The median tumor size was 4.96 mm (range, 1-22) in diameter, and 264 (95%) lesions were confined to the mucosa and submucosal layer. The en-bloc resection rate was 99% and all patients achieved endoscopically complete resection. The H-CR rates were 75, 74, and 73% for conventional EMR, EMR using a dual-channel endoscope, and EMR after precutting, respectively. Multivariate analysis showed that H-CR was associated with tumor size regardless of endoscopic treatment modalities (p?=?0.023). Of the 277 patients, 183 (66%) underwent at least 1 endoscopic follow-up. Three (2%) of these 183 patients had tumor recurrence, which was diagnosed at a median of 62.5 months (range 19-98) after endoscopic resection. There was 1 case of disease-related death, which occurred 167 months after endoscopic treatment because of bone marrow failure that resulted from tumor metastasis.CONCLUSIONSAlthough the en-bloc resection rate was 99% in rectal NETs, H-CR rates were 72-74% for various EMR procedures. H-CR may be associated with tumor size regardless of endoscopic treatment modalities.

Project description:ObjectivesTo investigate the treatment effects of endoscopic submucosal dissection (ESD) versus endoscopic mucosal resection (EMR) for early gastric cancer (EGC).DesignMeta-analysis.MethodsWe systematically searched three electronic databases, including PubMed, EmBase and the Cochrane library for studies published with inception to January 2018. The eligible studies should be evaluated for the efficacy and safety of ESD versus EMR for patients with EGC. The summary ORs and standard mean differences (SMDs) with 95% CIs were employed as effect estimates. Sensitivity analyses were conducted to evaluate the impact of single study on overall analysis. Subgroup analyses were performed for investigated outcomes to evaluate the treatment effects of ESD versus EMR for patients with EGC with specific subsets.ResultsEighteen studies, with a total of 6723 patients with EGC, were included in final analysis. The summary ORs indicated that patients with EGC who received ESD were associated with an increased incidence of en bloc resection (OR: 9.00; 95% CI: 6.66 to 12.17; p<0.001), complete resection (OR: 8.43; 95% CI: 5.04 to 14.09; p<0.001) and curative resection (OR: 2.92; 95% CI: 1.85 to 4.61; p<0.001) when compared with EMR. Furthermore, ESD was associated with lower risk of local recurrence (OR: 0.18; 95% CI: 0.09 to 0.34; p<0.001). In addition, there was no significant difference between ESD and EMR for the risk of bleeding (OR: 1.26; 95% CI: 0.88 to 1.80; p=0.203). Though, ESD was correlated with greater risk of perforation (OR: 2.55; 95% CI: 1.48 to 4.39; p=0.001), and longer operation time (SMD: 1.12; 95% CI: 0.13 to 2.10; p=0.026) as compared with EMR. Additionally, several different features observed in included studies and patients could bias the effectiveness of ESD versus EMR in patients with EGC.ConclusionsESD is superior than EMR for en bloc resection, complete resection, curative resection and local recurrence, while it increased perforation risk and longer operation time.

Dataset Information

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

Introduction

Methods

Results

Discussion

Trial registration

Publications

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

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