Medical School of Chinese PLA: Chinese PLA General Hospital, Beijing, 100853, China.
School of Medicine, Nankai University, Tianjin, 300071, China.
BMC Cancer. 2022 Mar 24;22(1):318. doi: 10.1186/s12885-022-09375-w.
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.
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.
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.
Clinical Trial.gov ID: NCT04910789 May 29, 2021. Name: S2AEG.
迄今为止，食管胃结合部（Siewert Ⅱ型）腺癌（AEG）可以通过经腹经食管裂孔（TH）或右胸腹联合（RTA）途径进行根治性切除。由于缺乏高质量的直接证据，对于 Siewert Ⅱ型 AEG 的合适手术途径仍存在争议。目前，只有少数回顾性研究，结果也存在差异。因此，需要前瞻性随机临床试验来比较 TH 和 RTA 途径在可切除 Siewert Ⅱ型 AEG 患者中的生存、肿瘤学结果、安全性和效率以及生活质量。
将进行一项名为 S2AEG 的前瞻性、多中心、开放、随机、平行对照研究。符合纳入标准但不符合排除标准的 312 名患者将参加试验，并随机分为 TH（156）和 RTA（156）两组。主要疗效终点是手术后 3 年无病生存率（DFS）。R0 切除率、浸润和解剖淋巴结的数量和部位、术后并发症、住院天数和生活质量是次要终点。
本研究是第一项旨在比较 TH 和 RTA 途径在可切除 Siewert Ⅱ型 AEG 患者中的手术结果的前瞻性随机对照试验。假设与 RTA 组相比，TH 组患者在获得等效的肿瘤学结果和生存的同时，能够保持可接受的生活质量。我们的研究结果将为 Siewert Ⅱ型 AEG 患者的合适手术途径提供高级别的临床证据。本研究于 2019 年 11 月启动，将在最后一名参与者入组 3 年后完成。
ClinicalTrials.gov 注册号：NCT04910789，2021 年 5 月 29 日。名称：S2AEG。
