手工分层端端套入式吻合技术与器械吻合技术在胸腹腔镜联合食管癌根治术中的对比研究

Layered hand⁃sewn end to end invagination anastomosis vs instrument anastomosis in combined thoraco⁃scopic and laparoscopic definitive resection for esophageal cancer

目的对比在胸腹腔镜联合食管癌根治术中应用手工分层端端套入式吻合技术与器械吻合技术的术后特点及安全性的差异。方法本研究设计为回顾性探索研究,针对自2018年1月1日至2019年12月31日在科室就诊的新诊断食管癌患者,根据患者在临床实践中接受的手术治疗方式分为观察组(手工分层端端套入式吻合术)和对照组(器械吻合术)。收集整理患者的基线临床资料,围术期的临床表现资料,出院后对患者进行定期随访获取患者的预后数据。比较两组患者的术中指标和不良反应的差异。分析两组患者无疾病生存期(disease⁃free survival,DFS)和总生存期(overall survival,OS)的差异。结果研究纳入123例接受手术切除治疗的食管癌患者,其中观察组63例,对照组60例。入组研究的患者均进行了定期的随访,36个月后观察组的吻合口瘘发生率显著低于对照组(1.6%vs.10.0%,P=0.045)。36个月后观察组吻合口狭窄发生率显著低于对照组(6.3%vs.20.0%,P=0.024)。36个月后观察组胃食管反流发生率显著低于对照组(22.2%vs.41.7%,P=0.021)。围术期安全性指标方面,观察组和对照组患者在肺部感染、切口感染、心律失常和胸腔积液等不良事件方面差异均无统计学意义(P>0.05)。预后数据结果提示观察组中位DFS显著高于对照组(47.1个月vs.39.3个月,χ^(2)=4.300,P=0.038)。观察组中位OS显著长于对照组(NR vs.44.1个月,χ^(2)=5.733,P=0.017)。结论胸腹腔镜联合食管癌根治手术中应用手工分层端端套入式吻合技术可以降低吻合口瘘、吻合口狭窄和胃食管反流的发生率,安全性良好,初步的预后数据显示可能会给患者带来长期的生存获益。

Objective To compare the efficacy and safety of layered hand⁃sewn end to end invagination anastomosis versus instrument anastomosis in combined thoracoscopic and laparoscopic definitive resection for esophageal cancer.Methods The present study was designed as a retrospective exploratory study,patients with newly diagnosed esophageal cancer who were admitted to the department from January 1st 2018 to December 31st 2019 were assigned to experimental group(layered hand⁃sewn end to end invagination anastomosis)and control group(instrument anastomosis)based on the actual surgical therapeutic options received in clinical practice.The baseline clinical characteristics and perioperative clinical manifestations of the patients were collected and were followed up regularly after hospitalization to obtain the prognostic data of the patients.Regarding the observational endpoints,the differences of perioperative indicators and adverse events between the two groups were compared.The disease⁃free survival(DFS)and overall survival(OS)were compared between the two groups.Results A total of 123 patients with esophageal cancer who underwent surgical resection were enrolled,including 63 patients in the experimental group and 60 patients in the control group.All patients were followed up regularly,the incidence of anastomotic leakage in the experimental group was significantly lower than that of the control group after 36 months(1.6%vs.10.0%,P=0.045).The incidence of anastomotic stenosis in the experimental group was significantly lower than that of the control group after 36 months(6.3%vs.20.0%,P=0.024).Furthermore,the incidence of gastroesophageal reflux in the experimental group was significantly lower than that of the control group(22.2%vs.41.7%,P=0.021).In terms of perioperative safety profile,no significant differences in adverse reactions such as pulmonary infection,incision infection,arrhythmia and pleural effusion between the two groups were noted(P>0.05).Prognostic data showed that the median DFS of the experimental group was longer than that of the control group(47.1 months vs.39.3 months,χ^(2)=4.300,P=0.038).The median OS of the experimental group was longer than that of the control group(NR vs.44.1 months,χ^(2)=5.733,P=0.017).Conclusion Layered hand⁃sewn end to end invagination anastomosis combined with thoracoscopic and laparoscopic definitive resection of esophageal cancer might attenuate the incidence of anastomotic leakage,anastomotic stenosis and gastroesophageal reflux with tolerable safety profile.Preliminary prognostic data suggested that it might bring long⁃term survival benefits for the patients.The conclusions should be confirmed in prospective clinical trials subsequently.