Annals of translational medicine · 2022
Transcervical versus transthoracic minimally invasive esophagectomy: a randomized and controlled trial protocol.
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Lin Miao, He Mengjiang, Yu Qiaomeng, Zhang Yiqun, Shen Yaxing, Fan Hong, Zhou Pinghong, Tan Lijie
Аннотация
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.
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.