经宫颈与经胸微创食管切除术：一项随机对照试验方案

Transcervical versus transthoracic minimally invasive esophagectomy: a randomized and controlled trial protocol.

作者信息

Lin Miao, He Mengjiang, Yu Qiaomeng, Zhang Yiqun, Shen Yaxing, Fan Hong, Zhou Pinghong, Tan Lijie

机构信息

Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.

Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China.

出版信息

Ann Transl Med. 2022 Apr;10(7):422. doi: 10.21037/atm-22-1180.

DOI:10.21037/atm-22-1180

PMID:35530957

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9073779/

Abstract

BACKGROUND

Anatomically, the esophagus is located within the mediastinum, and thus it potentially a transcervical approach for esophagectomy, which avoids thoracic manipulation, could be an alternative to transthoracic esophagectomy for the surgical resection of esophageal cancer. A modified transcervical minimally invasive esophagectomy (MIE), laparo-gastroscopic esophagectomy (LGE), was recently introduced using an integrated gastroscope to mobilize the esophagus. As such, a randomized controlled trial (RCT) is necessary to validate its value compared to transthoracic MIE, which carries a high risk of morbidity due to thoracic manipulation.

METHODS

This prospective study plans to enroll patients with resectable esophageal cancer with a pathological diagnosis of squamous cell carcinoma or adenocarcinoma patients over a 2-year period. Patients will be randomly assigned to one of 2 groups in a 1:1 ratio: patients in Group A will radical LGE and patients in Group B will receive radical laparo-thoracoscopic esophagectomy (LTE). Perioperative and long-term outcomes of all patients will be collected and analyzed. The primary end point will be perioperative morbidity, and the secondary end points will include 5-year overall survival (OS) and disease-free survival (DFS) and quality of life (QOL) score. Other data that will be collected and compared between the groups include the number of harvested lymph nodes, surgical Apgar score, and duration of operation.

DISCUSSION

Transthoracic MIE is the most widely accepted approach for treating esophageal cancer. In this RCT, transthoracic MIE and transcervical LGE will be compared with respect to oncological and surgical outcomes (oncological none-inferiority and surgical superiority).

TRIAL REGISTRATION

This study is registered in Chinese Clinical Trial Registry (ChiCTR2200055312) with the name of 'Transcervical versus Transthoracic Minimally Invasive Esophagectomy: A Randomized and Controlled Trial' on January 6, 2022. Details can be found on http://www.chictr.org.cn/showproj.aspx?proj=133224.

摘要

背景

从解剖学角度来看，食管位于纵隔内，因此经颈部入路进行食管切除术有可能避免胸腔操作，对于食管癌手术切除而言，它可能是经胸食管切除术的一种替代方法。最近引入了一种改良的经颈部微创食管切除术（MIE），即腹腔镜 - 胃镜联合食管切除术（LGE），使用一体化胃镜来游离食管。因此，有必要进行一项随机对照试验（RCT），以验证其与经胸MIE相比的价值，经胸MIE因胸腔操作而具有较高的发病风险。

方法

这项前瞻性研究计划在2年时间内纳入经病理诊断为鳞状细胞癌或腺癌且可切除的食管癌患者。患者将按1:1的比例随机分为两组：A组患者接受根治性LGE，B组患者接受根治性腹腔镜 - 胸腔镜联合食管切除术（LTE）。收集并分析所有患者的围手术期和长期结局。主要终点将是围手术期发病率，次要终点将包括5年总生存期（OS）、无病生存期（DFS）和生活质量（QOL）评分。两组之间还将收集和比较的其他数据包括获取的淋巴结数量、手术阿普加评分和手术持续时间。