胃癌术后发生十二指肠残端漏风险:一项前瞻性多中心观察性研究  

The incidence of duodenal stump leakage after gastrectomy for gastric cancer:A prospective multicenter observational study

作　　者：苗儒林[1] 任双义[2] 张涛[3] 田艳涛 曲建军[5] 潘源 王权[7] 梁品[8] 于文滨[9] 李子禹[1] MIAO Ru-lin;REN Shuang-yi;ZHANG Tao;TIAN Yan-tao;QU Jian-jun;PAN Yuan;WANG Quan;LIANG Pin;YU Wen-bin;LI Zi-yu(Key laboratory of Carcinogenesis and Translational Research(Ministry of Education),Gastrointestinal Cancer Center,Peking University Cancer Hospital&Institute,Beijing 100142,China;Department of Gastrointestinal Surgery,The Second Affiliated Hospital of Dalian Medical University,Dalian 116027,China;Department of Gastric Surgery,Cancer Hospital of China Medical University,Liaoning Cancer Hospital,Shenyang 110042,China;Department of Pancreatic and Gastric Surgery,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;Department of Oncology Surgery,Weifang People’s Hospital,Weifang 261000,China;Department of Gastrointestinal Cancer,Tianjin Medical University Cancer Institute and Hospital,National Clinical Research Center for Cancer,Key Laboratory of Cancer Prevention and Therapy,Tianjin,Tianjin’s Clinical Research Center for Cancer,Tianjin 300060,China;Department of Gastrocolorectal Surgery,General Surgery Center,the First Hospital of Jilin University,Changchun 130021,China;Department of Gastrointestinal Surgery,the First Affiliated Hospital of Dalian Medical University,Dalian 116011,China;Department of General Surgery,Qilu Hospital of Shandong University,Jinan 250012,China)

机构地区：[1]北京大学肿瘤医院暨北京市肿瘤防治研究所,胃肠肿瘤中心,恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142 [2]大连医科大学附属第二医院胃肠外科,辽宁大连116027 [3]辽宁省肿瘤医院胃外科,辽宁沈阳110042 [4]国家癌症中心,国家肿瘤临床医学研究中心,中国医学科学院北京协和医学院肿瘤医院胰胃外科,北京100021 [5]潍坊市人民医院胃肠外科,山东潍坊261000 [6]天津医科大学肿瘤医院胃部肿瘤科,天津300060 [7]吉林大学第一医院普通外科中心胃结直肠外科,吉林长春130021 [8]大连医科大学附属第一医院胃肠外科,辽宁大连116011 [9]山东大学齐鲁医院普通外科,山东济南250012

出　　处：《中国实用外科杂志》2025年第3期309-315,共7页Chinese Journal of Practical Surgery

基　　金：首都卫生发展科研专项基金项目(首发2024-1-2152)。

摘　　要：目的探讨当前手术条件下胃癌术后十二指肠残端漏(DSL)的发生率,评估可能的危险因素及术后引流液检测的诊断价值。方法采用前瞻性多中心观察性研究方法,纳入国内9家诊疗中心2021年2月至2022年12月接受胃癌手术的1036例病人。术后第1、3、5、7天动态监测引流液淀粉酶及直接胆红素水平。主要研究终点为DSL发生率,次要终点包括Clavien-Dindo分级、并发症发生率及引流液生化指标动态变化。结果DSL总发生率为0.97%(10/1036),其中Clavien-Dindo分级Ⅱ级(50.0%)和Ⅲa级(30.0%)占主导。DSL组病人心脑血管合并症比例显著高于非DSL组(60.0%vs.23.7%,P=0.016),手工离断组DSL发生率显著高于器械闭合组(33.3%vs.0.9%,P=0.029)。DSL病人术后住院时间较非DSL组显著延长(24.4 d vs.10.9 d,P<0.01)。术后引流液淀粉酶及直接胆红素在DSL组呈持续升高趋势(术后第7天分别达35250.2 U/L和44.9μmol/L),但组间差异无统计学意义。所有DSL病例均通过禁食、胃肠减压、生长抑素、抗感染及充分引流治愈,无死亡病例。结论胃癌术后DSL发生率降至0.97%,器械闭合十二指肠残端安全可行。术后引流液淀粉酶及直接胆红素动态监测可能为早期诊断提供依据,但需更大样本验证。Objective To explore the incidence,risk factors,and diagnostic value of postoperative drainage fluid analysis in detecting duodenal stump leakage(DSL)following gastric cancer surgery under current surgical conditions in China.Methods A prospective multicenter observational study was conducted,enrolling 1036 patients who underwent gastric cancer surgery at nine centers in China between February 2021 and December 2022.Postoperative drainage fluid amylase and direct bilirubin levels were monitored on days 1,3,5,and 7.The primary endpoint was the incidence of DSL,while secondary endpoints included Clavien-Dindo classification,complication rates,and dynamic changes in biochemical indicators of drainage fluid.Results The overall incidence of DSL was 0.97%(10/1036),with the majority of cases classified as Clavien-Dindo gradeⅡ(50.0%)andⅢa(30.0%).The proportion of patients with cardiovascular and cerebrovascular comorbidities was significantly higher in the DSL group compared to the non-DSL group(60.0%vs.23.7%,P=0.016).The incidence of DSL was significantly higher in the hand-sewn anastomosis group compared to the stapler closure group(33.3%vs.0.9%,P=0.029).The hospital stay for patients with DSL was significantly longer than for those without DSL(24.4 days vs.10.9 days,P<0.001).Amylase and direct bilirubin levels in the drainage fluid showed a persistent increase in the DSL group(reaching 35250.2 U/L and 44.9μmol/L on day 7 postoperatively,respectively),but the differences between groups were not statistically significant.All DSL cases were cured with fasting,gastrointestinal decompression,somatostatin,antibiotics,and adequate drainage,with no mortality.Conclusion The incidence of DSL after gastric cancer surgery has decreased to 0.97%,and stapler closure of the duodenal stump is a safe and feasible approach.Dynamic monitoring of amylase and direct bilirubin levels in postoperative drainage fluid may provide early diagnostic evidence,but larger sample studies are needed for validation.

关 键 词：胃癌 十二指肠残端漏 前瞻性多中心研究 直线切割闭合器 Clavien-Dindo分级 引流液淀粉酶 直接胆红素 手工离断 

分 类 号：R6[医药卫生—外科学]