Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Mayo Clinic, Rochester, MN, USA.
BMC Surg. 2023 Sep 1;23(1):262. doi: 10.1186/s12893-023-02163-8.
The current standard operation for proximal gastric and gastroesophageal junction (P/GEJ) cancers with limited esophageal extension is total gastrectomy (TG). TG is associated with impaired appetite and weight loss due to the loss of gastric functions such as production of ghrelin and with anemia due to intrinsic factor loss and vitamin B malabsorption. Theoretically, proximal gastrectomy (PG) can mitigate these problems by preserving gastric function. However, PG with direct esophagogastric reconstruction is associated with severe postoperative reflux, delayed gastric emptying, and poor quality of life (QoL). Minimally invasive PG (MIPG) with antireflux techniques has been increasingly performed by experts but is technically demanding owing to its complexity. Moreover, the actual advantages of MIPG over minimally invasive TG (MITG) with regards to postoperative QoL are unknown. Our overall objective of this study is to determine the short-term QoL benefits of MIPG. Our central hypotheses are that MIPG is safe and that patients have improved appetite after MIPG with effective antireflux techniques, which leads to an overall QoL improvement when compared with MITG.
Enrollment of a total of 60 patients in this prospective survey-collection study is expected. Procedures (MITG versus MIPG, antireflux techniques for MIPG [double-tract reconstruction versus the double-flap technique]) will be chosen based on surgeon and/or patient preference. Randomization is not considered feasible because patients often have strong preferences regarding MITG and MIPG. The primary outcome is appetite level (reported on a 0-10 scale) at 3 months after surgery. With an expected 30 patients per cohort (MITG versus MIPG), this study will have 80% power to detect a one-point difference in appetite level. Patient-reported outcomes will be longitudinally collected (including questions about appetite and reflux), and specific QoL items, body weight, body mass index and ghrelin, albumin, and hemoglobin levels will be compared.
Surgeons from the US, Japan, and South Korea formed this collaboration with the agreement that the surgical approach to P/GEJ cancers is an internationally important but controversial topic that requires immediate action. At the completion of the proposed research, our expected outcome is the establishment of the benefit and safety of MIPG.
This trial was registered with Clinical Trials Reporting Program Registration under the registration number NCI-2022-00267 on January 11, 2022, as well as with ClinicalTrials.gov under the registration number NCT05205343 on January 11, 2022.
对于局限性食管延伸的近端胃和胃食管交界处（P/GEJ）癌症，目前的标准手术是全胃切除术（TG）。由于胃功能丧失，如胃饥饿素的产生，以及内因子丢失和维生素 B 吸收不良导致贫血，TG 会导致食欲下降和体重减轻。理论上，通过保留胃功能，近端胃切除术（PG）可以减轻这些问题。然而，直接食管胃重建的 PG 与严重的术后反流、胃排空延迟和生活质量（QoL）差有关。具有抗反流技术的微创 PG（MIPG）已被专家越来越多地采用，但由于其复杂性，技术要求很高。此外，MIPG 与微创 TG（MITG）相比，在术后 QoL 方面的实际优势尚不清楚。我们进行这项研究的总体目标是确定 MIPG 的短期 QoL 获益。我们的中心假设是 MIPG 是安全的，并且患者在接受具有有效抗反流技术的 MIPG 后食欲得到改善，与 MITG 相比，总体 QoL 得到改善。
预计将有 60 名患者参与这项前瞻性调查收集研究。根据外科医生和/或患者的偏好，选择手术（MITG 与 MIPG，MIPG 的抗反流技术[双管重建与双瓣技术]）。由于患者对 MITG 和 MIPG 往往有强烈的偏好，因此不考虑随机化。主要结局是术后 3 个月时的食欲水平（以 0-10 分报告）。每个队列（MITG 与 MIPG）预计有 30 名患者，这项研究将有 80%的效力来检测食欲水平的一分差。将纵向收集患者报告的结果（包括关于食欲和反流的问题），并比较特定的 QoL 项目、体重、体重指数和胃饥饿素、白蛋白和血红蛋白水平。
来自美国、日本和韩国的外科医生组成了这个合作团队，他们一致认为 P/GEJ 癌症的手术方法是一个具有国际重要性但有争议的话题，需要立即采取行动。在拟议研究完成后，我们预计的结果是确定 MIPG 的获益和安全性。
这项试验于 2022 年 1 月 11 日在临床试验报告计划注册处注册，注册号为 NCI-2022-00267，并于 2022 年 1 月 11 日在 ClinicalTrials.gov 注册，注册号为 NCT05205343。
