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二期临床试验评估经肛门内镜微创手术治疗直肠癌的疗效。

Phase II Clinical Trial to Evaluate the Efficacy of Transanal Endoscopic Total Mesorectal Excision for Rectal Cancer.

机构信息

Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.

Biometrics Research Branch, Research Institute and Hospital, National Cancer Center, Goyang, Korea.

出版信息

Dis Colon Rectum. 2018 May;61(5):554-560. doi: 10.1097/DCR.0000000000001058.

DOI:10.1097/DCR.0000000000001058
PMID:29624549
Abstract

BACKGROUND

Total mesorectal excision has become the standard treatment for rectal cancer, and several investigators have shown that a transanal approach is a feasible option.

OBJECTIVE

This study aimed to evaluate the efficacy of transanal endoscopic total mesorectal excision in patients with rectal cancer.

DESIGN

This study was a prospective, single-arm phase II trial. It was registered on clinicaltrials.gov under identifier NCT02406118.

SETTINGS

Inpatients at a hospital specializing in oncology were selected.

PATIENTS

This prospective study enrolled 49 patients with rectal cancer located 3 to 12 cm from the anal verge who were scheduled to undergo radical surgery.

INTERVENTIONS

Laparoscopy-assisted transanal total mesorectal excision was performed.

MAIN OUTCOME MEASURES

The primary end point was total mesorectal excision quality and circumferential resection margin. Secondary end points included the number of harvested lymph nodes, operation time, and 30-day postoperative complications.

RESULTS

From March 2015 to April 2016, 32 men and 17 women with rectal cancer were enrolled. The mean age was 61.2 years, and mean BMI was 23.3 kg/m. The mean operating time was 158 minutes, and the mean estimated blood loss was 89.3 mL. There were no intraoperative complications and no conversions to open surgery. Successful treatment based on total mesorectal excision quality and circumferential resection margin was achieved in 45 patients (91.8%). Fifteen patients (30.6%) had 30-day postoperative complications, including 7 (14.3%) with anastomotic dehiscence, 5 (10.2%) with urinary retention, 2 (4.1%) with abdominal wound complications, and 1 (2.0%) with ileus. There was no postoperative mortality.

LIMITATIONS

This was a noncomparative single-arm trial conducted at a single institution.

CONCLUSIONS

Transanal endoscopic total mesorectal excision showed acceptable results based on perioperative and short-term oncologic outcomes. Further investigations are necessary to show the benefits and long-term outcomes of this procedure. See Video Abstract at http://links.lww.com/DCR/A563.

摘要

背景

全直肠系膜切除术已成为直肠癌的标准治疗方法,有几位研究者已经表明经肛门入路是一种可行的选择。

目的

本研究旨在评估经肛门内镜全直肠系膜切除术治疗直肠癌的疗效。

设计

本研究为前瞻性单臂 II 期试验。它在 clinicaltrials.gov 上以标识符 NCT02406118 注册。

地点

在一家专门从事肿瘤学的医院选择住院患者。

患者

本前瞻性研究纳入了 49 例距肛门 3 至 12cm 的直肠癌患者,这些患者计划接受根治性手术。

干预措施

腹腔镜辅助经肛门全直肠系膜切除术。

主要观察指标

主要终点是全直肠系膜切除质量和环周切缘。次要终点包括淋巴结检出数、手术时间和 30 天术后并发症。

结果

2015 年 3 月至 2016 年 4 月,共纳入 32 名男性和 17 名女性直肠癌患者。平均年龄为 61.2 岁,平均 BMI 为 23.3kg/m2。平均手术时间为 158 分钟,平均估计出血量为 89.3mL。无术中并发症,无中转开腹手术。45 例(91.8%)患者基于全直肠系膜切除质量和环周切缘达到成功治疗。15 例(30.6%)患者发生 30 天术后并发症,包括 7 例(14.3%)吻合口裂开、5 例(10.2%)尿潴留、2 例(4.1%)腹部伤口并发症和 1 例(2.0%)肠梗阻。无术后死亡。

局限性

这是一项在单中心进行的非对照单臂试验。

结论

经肛门内镜全直肠系膜切除术在围手术期和短期肿瘤学结果方面显示出可接受的结果。需要进一步研究以显示该手术的益处和长期结果。见视频摘要,网址:http://links.lww.com/DCR/A563。

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