Transanal vs Laparoscopic Total Mesorectal Excision and 3-Year Disease-Free Survival in Rectal Cancer

作者：Ziwei Zeng, Shuangling Luo, Hong Zhang, Miao Wu, Dan Ma, Quan Wang, Ming Xie, Qing Xu, Jun Ouyang, Yi Xiao, Yongchun Song, Bo Feng, Qingwen Xu, Yanan Wang, Yi Zhang, Lishuo Shi, Li Ling, Xingwei Zhang, Liang Huang, Zuli Yang, Junsheng Peng, Xiaojian Wu, Donglin Ren, Meijin Huang, Ping Lan, Jianping Wang, Weidong Tong, Mingyang Ren, Huashan Liu, Liang Kang, Chinese Transanal Endoscopic Surgery Collaborative (CTESC) Group, Xiaobin Zheng, Yanping Liu, Zijun Huang, Yujie Hou, Zhanzhen Liu, Yonghua Cai, Sicong Lai, Huanxin Hu, Dingsheng Liu, Jinchun Cong, Meng-yin Peng, Xian Liu, X. Yang, Dong-bing Zhou, Yue Tian, Jingwang Ye, Huichao Zheng, Guoqing Chen, Jianghong Chen, Meng Li, Jiaxin Zhang, Gong Yang, Xing-qin Wang, Fujian Xu, Z Q Li, Lei Gu, Ye Liu, Ling Zhan, Yiwen Zhang, Junyang Lu, Jiajia Qian, Rong Yang, Rui-xiang Tang, Zhenghao Cai, Feipeng Xu, Jie Fu, Mingyi Wu, Kai Gao · 发表于：JAMA · 年份：2025 · DOI：10.1001/jama.2024.24276 · 被引用次数：35 · 研究领域：Colorectal Cancer Surgical Treatments、Colorectal and Anal Carcinomas、Anorectal Disease Treatments and Outcomes

Importance: Previous studies have demonstrated the advantages of short-term histopathological outcomes and complications associated with transanal total mesorectal excision (TME) compared with laparoscopic TME. However, the long-term oncological outcomes of transanal TME remain ambiguous. This study aims to compare 3-year disease-free survival of transanal TME with laparoscopic TME. Objective: To evaluate 3-year disease-free survival between transanal TME and laparoscopic TME in patients with rectal cancer. Design, Setting, and Participants: This randomized, open-label, noninferiority, phase 3 clinical trial was performed in 16 different centers in China. Between April 2016 and June 2021, a total of 1115 patients with clinical stage I to III mid-low rectal cancer were enrolled. The last date of participant follow-up was in June 2024. Interventions: Participants were randomly assigned in a 1:1 ratio before their surgical procedure to undergo either transanal TME (n = 558) or laparoscopic TME (n = 557). Main Outcomes and Measures: The primary end point was 3-year disease-free survival, with a noninferiority margin of -10% for the comparison between transanal TME and laparoscopic TME. Secondary outcomes included 3-year overall survival and 3-year local recurrence. Results: In the primary analysis set, the median patient age was 60 years. A total of 692 male and 397 female patients were included in the analysis. Three-year disease-free survival was 82.1% (97.5% CI, 78.4%-85.8%) f...