Equal short-term outcomes of intracorporeal mechanical gastrogastrostomy in laparoscopic pylorus-preserving gastrectomy for cT1N0 gastric cancer in the middle stomach compared with the extracorporeal hand-sewing method

Hiroki Harada, Kojiro Eto, Manabu Ohashi, Nozomi Kurihara, Motonari Ri, Rie Makuuchi, Satoshi Ida, Masaru Hayami, Koshi Kumagai, Takeshi Sano, Souya Nunobe
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Abstract

Background

Intracorporeal mechanical gastrogastrostomy (IMG) techniques have recently been developed and their short-term safety was presented in their initial evaluation. However, whether they are comparable to extracorporeal hand-sewing gastrogastrostomy (EHG) remains unclear. The aim of the study is to establish the safety of IMG in totally laparoscopic pylorus-preserving gastrectomy (TLPPG) compared to EHG in laparoscopy-assisted pylorus-preserving gastrectomy (LAPPG).

Methods

We retrospectively analyzed the short-term outcomes of patients with middle-third early gastric cancer who underwent LAPPG or TLPPG between 2005 and 2022. The primary objective of this study was to evaluate the non-inferiority of IMG to EHG in terms of safety, with the primary endpoint being the risk difference in anastomosis-related complications (ARCs). The sample size required to achieve a statistical power of 80% for the non-inferiority test was 971 with a one-sided alpha level of 5% and non-inferiority of 5%.

Results

The analysis included a total of 1,021 patients who underwent LAPPG or TLPPG during the study period. Among them, 488 patients underwent EHG, while 533 underwent IMG. The incidences of ARCs were 11.3% and 11.4% in EHG and IMG, respectively. The observed difference in incidence was 0.0017 (90% confidence interval − 0.0313 to 0.0345), which statistically demonstrated the non-inferiority of IMG to EHG in the incidence of ARCs. Among other complications, the incidence of wound infection in IMG was lower than that in EHG.

Conclusion

IMG is safe regarding ARCs compared with EHG. These results will encourage surgeons to introduce IMG for patients with early middle gastric cancer.

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体腔内机械胃切除术与体外手缝法在腹腔镜保留幽门胃切除术治疗中胃cT1N0胃癌中的短期疗效相同
背景体外机械胃造瘘术(IMG)技术是最近开发出来的,其短期安全性已在初步评估中进行了介绍。然而,它们是否可与体外手缝胃造瘘术(EHG)相媲美仍不清楚。本研究旨在确定在全腹腔镜下保留幽门胃切除术(TLPPG)中使用IMG与在腹腔镜辅助下保留幽门胃切除术(LAPPG)中使用EHG相比的安全性。方法我们回顾性分析了2005年至2022年间接受LAPPG或TLPPG的中段早期胃癌患者的短期疗效。本研究的主要目的是评估 IMG 在安全性方面是否优于 EHG,主要终点是吻合相关并发症(ARC)的风险差异。在单侧α水平为5%和非劣效性为5%的条件下,非劣效性检验的统计功率达到80%所需的样本量为971例。其中,488 名患者接受了 EHG,533 名患者接受了 IMG。EHG 和 IMG 的 ARC 发生率分别为 11.3% 和 11.4%。观察到的发生率差异为 0.0017(90% 置信区间 - 0.0313 至 0.0345),这在统计学上证明了 IMG 在 ARC 发生率方面不劣于 EHG。在其他并发症中,IMG 的伤口感染发生率低于 EHG。这些结果将鼓励外科医生对早中期胃癌患者采用IMG。
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