The abdominal-transhiatal surgical approach versus the thoracoabdominal surgical approach in Siewert type II adenocarcinoma of the esophagogastric junction: protocol for a multicenter prospective, open, parallel, and randomized controlled trial

BMC Cancer

Xin Guo¹  Liyu Zhang²  Xinxin Wang²  Tianyu Xie²  Di Wu²  Yixun Lu²  Ziyao Xu²  Qiying Song²  Lu Liu³  Xiongguang Li³  Shuo Li³ 

[1] Air Force Medical University Xijing Hospital: Xijing Hospital;Medical School of Chinese PLA: Chinese PLA General Hospital;School of Medicine, Nankai University;

关键词: Adenocarcinomas of the esophagogastric junction;    Siewert type II;    Abdominal-transhiatal;    Thoracoabdominal;   

DOI  :  10.1186/s12885-022-09375-w

来源: DOAJ

【 摘 要 】

Abstract Background To date, Siewert type II adenocarcinoma of the esophagogastric junction (ST-II AEG) can be removed radically utilizing either the abdominal-transhiatal (TH) or the right thoracoabdominal (RTA) approaches. Because of a paucity of high-quality direct evidence, the appropriate surgical approach for ST-II AEG remains debatable. In the present, only several retrospective studies are available, representing ambiguous results. Thus, prospective randomized clinical trials are demanded to compare the survival, oncological outcomes, safety and efficiency and life quality between the TH and RTA approach in patients with resectable AEG of Siewert type II. Methods A prospective, multicenter, open, randomized, and parallel controlled study named S2AEG will be conducted. Three hundred and twelve patients who match the inclusion criteria but not the exclusion criteria will be participating in the trial and randomly divided into the TH (156) and RTA (156) cohorts. The primary efficacy endpoint is the 3-year disease-free survival (DFS) following the operation. The rate of R0-resection, the number and site of lymph nodes infiltrated and dissected, postoperative complications, hospital days and life quality are the second endpoints. Discussion This study is the first prospectively randomized controlled trial aiming to compare the surgical outcomes between TH and RTA approaches in patients with resectable ST-II AEG. It is hypothesized that patients in the TH cohort would harvest equivalent oncological results and survival while maintaining acceptable life quality when compared to patients in the RTA cohort. Our findings will provide high-level clinical evidence for clinical decision-making on the appropriate surgical approach for patients with ST-II AEG. Embarked in November 2019, this research will be completed 3 years after the final participant’s enrolment date. Trial registration Clinical Trial.gov ID: NCT04910789 May 29, 2021. Name: S2AEG.

【 授权许可】

Unknown