经肛腔镜括约肌间切除术在低位直肠癌保肛中的应用价值

Application value of transanal endoscopic intersphincteric resection in sphincter preserva-tion for low rectal cancer

目的探讨经肛腔镜括约肌间切除术(taE-ISR)在低位直肠癌保肛中的应用价值。方法采用倾向评分匹配及回顾性队列研究方法。收集2017年1月至2021年12月上海交通大学医学院附属瑞金医院等5家医学中心收治的278例低位直肠癌患者的临床病理资料;男178例,女100例;年龄为58(49~64)岁。278例患者中,147例行taE-ISR,设为taE-ISR组,131例行经括约肌间切除术(ISR),设为ISR组。观察指标:(1)倾向评分匹配前及匹配后两组患者一般资料比较。(2)两组患者术中及术后结果比较。(3)两组患者长期随访结果。(4)影响低位直肠癌保肛的独立影响因素。倾向评分匹配按1∶1最近邻匹配法匹配,卡钳值为0.05。倾向评分匹配分析采用"Matching"包进行。正态分布的计量资料以x±s进行表示,组间比较采用Student′st检验;偏态分布的计量资料以M(Q_(1),Q_(3))表示,组间比较采用Wilcoxon秩和检验。计数资料以绝对数或百分比表示,组间比较采用Pearsonχ^(2)检验或Fisher确切概率法。采用Kaplan-Meier法计算生存率并绘制生存曲线,Log-Rank检验进行生存分析。多因素分析采用Logistic回归模型,使用"glm2"包进行,森林图显示影响低位直肠癌保肛的风险因素。结果(1)倾向评分匹配情况及匹配后两组患者一般资料比较。278例患者中,180例配对成功,taE-ISR组和ISR组各90例。倾向评分匹配后消除坐骨结节间径、坐骨结节至臀部皮肤距离因素混杂偏倚,具有可比性。(2)两组患者术中及术后结果比较。taE-ISR组患者远切缘阳性1例,标本质量完整88例,完成保肛88例。ISR组患者远切缘阳性8例、标本质量完整78例、完成保肛74例。两组患者上述指标比较,差异均有统计学意义(P<0.05)。(3)两组患者长期随访结果。taE-ISR组和ISR组患者的中位随访时间分别为4.3(3.8~5.0)年和4.1(3.4~4.7)年。taE-ISR组患者总生存率为100.0%,无病生存率为95.6%,累积复发率为2.2%。ISR组患者总生存率为98.9%,无病生存率为87.8%,累积复发率为10.0%。两组患者总生存率比较,差异无统计学意义(χ^(2)=0.97,P>0.05);无病生存率和累积复发率比较,差异均有统计学意义(χ^(2)=4.05,5.26,P<0.05)。(4)影响低位直肠癌保肛的危险因素分析。多因素分析结果显示:taE-ISR、肿瘤距肛缘距离、毗邻脏器损伤是低位直肠癌保肛的独立影响因素(优势比=0.86,0.88,1.35,95%可信区间为0.79~0.93,0.83~0.92,1.04~1.74,P<0.05)。进一步分析结果显示:21例taE-ISR组行新辅助治疗患者和19例ISR组行新辅助治疗患者完成保肛、排便功能障碍比较,差异均有统计学意义(P<0.05)。结论taE-ISR治疗低位直肠癌安全、可行。与ISR比较,taE-ISR可显著提高手术质量、保肛率和改善患者预后。

Objective To investigate the application value of transanal endoscopic inter-sphincteric resection(taE-ISR)in sphincter preservation for low rectal cancer.Methods The pro-pensity score matching and retrospective cohort study was conducted.The clinicopathological data of 278 patients with low rectal cancer who were admitted to 5 medical centers,including Ruijin Hospital of Shanghai Jiaotong University School of Medicine etal,from January 2017 to December 2021 were collected.There were 178 males and 100 females,aged 58(range,49-64)years.Of 278 patients,147 cases undergoing taE-ISR were divided into the taE-ISR group,and 131 cases undergoing intersphincteric resection(ISR)were divided into the ISR group.Observation indicators:(1)propen-sity score matching and comparison of general data of patients between the two groups after matching;(2)comparison of intraoperative and postoperative conditions between the two groups;(3)long-term follow-up of the two groups;(4)analysis of risk factors affecting sphincter preservation for low rectal cancer.Propensity score matching was done by the 1:1 nearest neighbor matching method,with a caliper value of 0.05.Propensity score matching analysis was done using the Matching package.Measurement data with normal distribution were represented as Mean±SD,and comparison between groups was conducted using the Student's t test.Measurement data with skewed distribution were represented as M(Q_(1),Q_(3)),and comparison between groups was conducted using the Wilcoxon rank sum test.Count data were described as absolute numbers or percentages,and comparison between groups was conducted using the Pearson chi-square test or Fisher exact probability.The Kaplan-Meier method was used to calculate survival rate and plot survival curve,and the Log-Rank test was used for survival analysis.Multivariate analysis was conducted using the Logistic regression model with the"glm2"package.The forest plot was used to show the risk factors affecting sphincter preser-vation for low rectal cancer.Results(1)Propensity score matching and comparison of general data of patients between the two groups after matching.Of 278 patients,180 cases were successfully matched,including 90 cases in the taE-ISR group and 90 cases in the ISR group,respectively.After propensity score matching,the elimination of distance between ischial tuberosities and distance from ischial tuberosity to the skin of buttocks confounding bias ensured comparability between the two groups.(2)Comparison of intraoperative and postoperative conditions between the two groups.Cases with positive distal margins,cases with specimen integrity,cases with sphincter preservation were 1,88,88 in the taE-ISR group and 8,78,74 in the ISR group,showing significant differences between the two groups(P<0.05).(3)Long-term follow-up of the two groups.The median follow-up time was 4.3(range,3.8-5.0)years of the taE-ISR group and 4.1(range,3.4-4.7)years of the ISR group.The overall survival rate,disease-free survival rate and cumulative recurrence rate were 100.0%,95.6%and 2.2%of the taE-ISR group,versus 98.9%,87.8%and 10.0%of the ISR group,showing no significant difference in overall survival rate between the two groups(χ^(2)=0.97,P>0.05)and significant differences in disease-free survival rate and cumulative recurrence rate between the two groups(χ^(2)=4.05,5.26,P<0.05).(4)Analysis of risk factors affecting sphincter preservation for low rectal cancer.Results of multivariate analysis showed that taE-ISR,distance from the tumor to the anus,and adjacent organ damage were independent factors affecting sphincter preservation for low rectal cancer(odds ratio=0.86,0.88,1.35,95%confidence interval as 0.79-0.93,0.83-0.92,1.04-1.74,P<0.05).In further analysis,there were significant differences in sphincter preservation and defecatory dysfunction between the 21 cases with neoadjuvant therapy in the taE-ISR group and the 19 cases with neoadjuvant therapy in the ISR group(P<0.05).Conclusions The taE-ISR is safe and feasible for patients with low rectal cancer.Compared with ISR,taE-ISR can significantly improve surgical quality,sphincter preservation rate and patient prognosis.