Randomised controlled trial of transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND Study)

被引：49

作者：

Barendse, Renee M. ^{[1
]}

Musters, Gijsbert D. ^{[1
]}

de Graaf, Eelco J. R. ^{[2
]}

van den Broek, Frank J. C. ^{[3
]}

Consten, Esther C. J. ^{[4
]}

Doornebosch, Pascal G. ^{[2
]}

Hardwick, James C. ^{[5
]}

de Hingh, Ignace H. J. T. ^{[6
]}

Hoff, Chrisiaan ^{[7
]}

Jansen, Jeroen M. ^{[8
]}

de Wit, A. W. Marc van Milligen ^{[9
]}

van der Schelling, George P. ^{[10
]}

Schoon, Erik J. ^{[11
]}

Schwartz, Matthijs P. ^{[12
]}

Weusten, Bas L. A. M. ^{[13
]}

Dijkgraaf, Marcel G. ^{[14
]}

Fockens, Paul ^{[15
]}

Bemelman, Willem A. ^{[1
]}

Dekker, Evelien ^{[15
]}

机构：

[1] Acad Med Ctr, Dept Surg, NL-1105 AZ Amsterdam, Netherlands

[2] IJsselland Hosp, Surg, Capelle aan den IJssel, Netherlands

[3] Maxima Med Ctr, Surg, Veldhoven, Netherlands

[4] Meander Med Ctr, Surg, Amersfoort, Netherlands

[5] Leiden Univ, Gastroenterol, Med Ctr, Leiden, Netherlands

[6] Catharina Hosp, Surg, Eindhoven, Netherlands

[7] Med Ctr Leeuwarden, Surg, Leeuwarden, Netherlands

[8] Onze Lieve Vrouw Hosp, Gastroenterol, Amsterdam, Netherlands

[9] Amphia Hosp, Gastroenterol, Breda, Netherlands

[10] Amphia Hosp, Surg, Breda, Netherlands

[11] Catharina Hosp, Gastroenterol, Eindhoven, Netherlands

[12] Meander Med Ctr, Gastroenterol, Amersfoort, Netherlands

[13] St Antonius Hosp, Gastroenterol, Nieuwegein, Netherlands

[14] Acad Med Ctr, Clin Res Unit, Amsterdam, Netherlands

[15] Acad Med Ctr, Gastroenterol, Amsterdam, Netherlands

来源：

GUT | 2018年 / 67卷 / 05期

关键词：

NONPEDUNCULATED COLORECTAL LESIONS; TERM-FOLLOW-UP; COLONOSCOPIC POLYPECTOMY; SUBMUCOSAL DISSECTION; COLON-CANCER; RECURRENCE; NEOPLASIA; EMR; METAANALYSIS; PREVENTION;

D O I：

10.1136/gutjnl-2016-313101

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Objective Non-randomised studies suggest that endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM), but EMR might be more cost-effective and safer. This trial compares the clinical outcome and cost-effectiveness of TEM and EMR for large rectal adenomas. Design Patients with rectal adenomas >= 3 cm, without malignant features, were randomised (1: 1) to EMR or TEM, allowing endoscopic removal of residual adenoma at 3 months. Unexpected malignancies were excluded postrandomisation. Primary outcomes were recurrence within 24 months (aiming to demonstrate non-inferiority of EMR, upper limit 10%) and the number of recurrence-free days alive and out of hospital. Results Two hundred and four patients were treated in 18 university and community hospitals. Twenty-seven (13%) had unexpected cancer and were excluded from further analysis. Overall recurrence rates were 15% after EMR and 11% after TEM; statistical non-inferiority was not reached. The numbers of recurrence-free days alive and out of hospital were similar (EMR 609 +/- 209, TEM 652 +/- 188, p=0.16). Complications occurred in 18% (EMR) versus 26% (TEM) (p=0.23), with major complications occurring in 1% (EMR) versus 8% (TEM) (p=0.064). Quality-adjusted life years were equal in both groups. EMR was approximately (sic) 3000 cheaper and therefore more cost-effective. Conclusion Under the statistical assumptions of this study, non-inferiority of EMR could not be demonstrated. However, EMR may have potential as the primary method of choice due to a tendency of lower complication rates and a better cost-effectiveness ratio. The high rate of unexpected cancers should be dealt with in further studies.

引用

页码：837 / 846

页数：10

共 50 条

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