Kitadani Junya, Hayata Keiji, Goda Taro, Tominaga Shinta, Fukuda Naoki, Nakai Tomoki, Nagano Shotaro, Ojima Toshiyasu, Shimokawa Toshio, Kawai Manabu
Second Department of Surgery, School of Medicine, Wakayama Medical University, 811-1, 811-1 Kimiidera, Wakayama, Japan.
Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.
Trials. 2025 Mar 29;26(1):111. doi: 10.1186/s13063-025-08823-9.
There are two types of methods of creating a gastric conduit after esophagectomy for patients with esophageal cancer: narrow gastric tube reconstruction or whole stomach reconstruction. Whole stomach reconstruction with good blood perfusion was reported in a prospective cohort study to be safe and that it has the possibility to prevent anastomotic leakage (AL). We therefore planned a randomized controlled phase III study to investigate the superiority of whole stomach reconstruction over narrow gastric tube reconstruction after esophagectomy for esophageal cancer.
This is a single center, two-arm, open-label, randomized phase III trial. We calculated that 65 patients in each arm of this study and total study population of 130 patients are required according to our historical data on narrow gastric tube reconstruction and prospective data on whole stomach reconstruction. In the narrow gastric tube group, a 3.5-cm-wide gastric tube is made along the greater curvature of the stomach using linear staplers. Otherwise, in the whole stomach group, after the lymphadenectomy of the lesser curvature and No.2, the stomach is cut just below the esophagogastric junction using a linear stapler. The primary endpoint of this study is the incidence of AL. Secondary endpoints are the occurrence rate of anastomotic stenosis, the occurrence rate of pneumonia, the occurrence rate of all postoperative complications, the occurrence rate of reflux esophagitis, quality of life evaluation by EORTC QLQ-C30 and EORTC OES-18, nutritional evaluation, the amount of blood loss, postoperative hospital stays, and blood flow evaluation. Complications are evaluated using the Clavien-Dindo classification (version 2.0), and those of grade II or higher are considered to be postoperative complications.
If the optimal method for creating a gastric conduit after esophagectomy is clarified, it may be possible to contribute to improving short-term and long-term surgical outcomes for patients undergoing surgery for esophageal cancer.
The protocol of ATHLETE trial was registered in the UMIN Clinical Trials Registry as UMIN000050677 ( http://www.umin.ac.jp/ctr/index.htm ). Date of registration: March 26, 2023. Date of first participant enrollment: March 27, 2023.
对于食管癌患者，食管切除术后创建胃通道有两种方法：窄胃管重建或全胃重建。一项前瞻性队列研究报告称，具有良好血液灌注的全胃重建是安全的，并且有可能预防吻合口漏（AL）。因此，我们计划开展一项随机对照III期研究，以调查食管癌食管切除术后全胃重建相对于窄胃管重建的优势。
这是一项单中心、双臂、开放标签的随机III期试验。根据我们关于窄胃管重建的历史数据和全胃重建的前瞻性数据，我们计算出本研究每组需要65例患者，总共需要130例患者。在窄胃管组中，使用线性吻合器沿胃大弯制作一条宽3.5厘米的胃管。否则，在全胃组中，在切除小弯和第2组淋巴结后，使用线性吻合器在食管胃交界处下方切断胃。本研究的主要终点是吻合口漏的发生率。次要终点包括吻合口狭窄的发生率、肺炎的发生率、所有术后并发症的发生率、反流性食管炎的发生率、欧洲癌症研究与治疗组织（EORTC）QLQ-C30和EORTC OES-18对生活质量的评估、营养评估、失血量、术后住院时间和血流评估。并发症使用Clavien-Dindo分类（第2.0版）进行评估，II级或更高等级的并发症被视为术后并发症。
如果明确了食管切除术后创建胃通道的最佳方法，可能有助于改善食管癌手术患者的短期和长期手术结果。
ATHLETE试验方案已在UMIN临床试验注册中心注册，注册号为UMIN（http://www.umin.ac.jp/ctr/index.htm）。注册日期：2023年3月26日。第一位参与者入组日期：2023年3月27日。
