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早期食管癌及癌前病变内镜黏膜下剥离术操作困难的影响因素分析

薛然荣, 沈裕厚, 方晓霞, 孙明明

薛然荣, 沈裕厚, 方晓霞, 等. 早期食管癌及癌前病变内镜黏膜下剥离术操作困难的影响因素分析[J]. 中华消化外科杂志, 2024, 23(10): 1326-1331. DOI: 10.3760/cma.j.cn115610-20240920-00425
引用本文: 薛然荣, 沈裕厚, 方晓霞, 等. 早期食管癌及癌前病变内镜黏膜下剥离术操作困难的影响因素分析[J]. 中华消化外科杂志, 2024, 23(10): 1326-1331. DOI: 10.3760/cma.j.cn115610-20240920-00425
Xue Ranrong, Shen Yuhou, Fang Xiaoxia, et al. Influencing factors analysis of difficulty in endoscopic submucosal dissection for early eso-phageal cancer and precancerous lesions[J]. Chinese Journal of Digestive Surgery, 2024, 23(10): 1326-1331. DOI: 10.3760/cma.j.cn115610-20240920-00425
Citation: Xue Ranrong, Shen Yuhou, Fang Xiaoxia, et al. Influencing factors analysis of difficulty in endoscopic submucosal dissection for early eso-phageal cancer and precancerous lesions[J]. Chinese Journal of Digestive Surgery, 2024, 23(10): 1326-1331. DOI: 10.3760/cma.j.cn115610-20240920-00425

早期食管癌及癌前病变内镜黏膜下剥离术操作困难的影响因素分析

基金项目: 

河南省卫生健康科研项目 LHGJ20220913

详细信息
    通讯作者:

    沈裕厚,Email:shy123456@126.com

Influencing factors analysis of difficulty in endoscopic submucosal dissection for early eso-phageal cancer and precancerous lesions

Funds: 

Research Project of Health and hygiene of Henan Province LHGJ20220913

More Information
  • 摘要:
    目的 

    探讨早期食管癌及癌前病变内镜黏膜下剥离术(ESD)操作困难的影响因素。

    方法 

    采用回顾性病例对照研究方法。收集2011年12月至2021年12月新乡市中心医院收治的331例早期食管癌及癌前病变患者的临床病理资料;男229例,女102例;年龄为(72.6±2.7)岁。患者均行ESD治疗。正态分布的计量资料采用x±s表示,组间比较采用t检验。计数资料以绝对数表示,组间比较采用χ²检验。单因素分析根据资料类型选择对应的统计学方法。多因素分析采用Logistic逐步回归模型。

    结果 

    (1)ESD手术情况。331例患者手术时间为(67±8)min,整块切除327例、分块切除4例。331例患者发生不良事件:出血1例、纵隔气肿2例、食管狭窄2例、食管穿孔3例,以上患者均采用保守治疗,无需手术。331例患者肿瘤浸润深度:上皮层109例、黏膜固有层155例、黏膜肌层9例、黏膜下层(<0.2 mm)12例、黏膜下层(≥0.2 mm)42例。331例患者中,鳞状细胞癌302例,腺癌29例。331例患者中,57例为ESD操作困难。(2)早期食管癌及癌前病变ESD操作困难的影响因素分析。多因素分析结果显示:食管左壁肿瘤、纵向肿瘤长径>30 mm和肿瘤周长与食管周长比>1/2是早期食管癌及癌前病变ESD操作困难的独立危险因素(优势比=3.903,6.699,5.387,95%可信区间为1.423~10.702,1.222~36.735,1.492~19.468,P<0.05)。

    结论 

    食管左壁肿瘤、纵向肿瘤长径>30 mm和肿瘤周长与食管周长比>1/2是早期食管癌及癌前病变ESD操作困难的独立危险因素。

    Abstract:
    Objective 

    To investigate the influencing factors associated with the difficulty in endoscopic submucosal dissection (ESD) for early esophageal cancer and precancerous lesions.

    Methods 

    The retrospective case⁃control study was conducted. The clinicopathological data of 331 patients with early esophageal cancer and precancerous lesions who were admitted to Xinxiang Central Hospital from December 2011 to December 2021 were collected. There were 229 males and 102 females, aged (72.6±2.7)years. All patients underwent ESD. Measurement data with normal distribution were represented as Mean±SD, and comparison between groups was analyzed using the t test. Count data were represented as absolute numbers, and comparison between groups was analyzed using the chi‑square test. The univariate analysis was performed using statistical methods appropriate to the data type. Multivariate analysis was conducted using the Logistic stepwise regre-ssion model.

    Results 

    (1) Surgical situations of ESD. The operation time of 331 patients was (67±8)minutes. There were 327 patients with en bloc resection, and 4 patients with piecemeal resection. Of the 331 patients, adverse events included bleeding in 1 case, pneumomediastinum in 2 cases, esophageal stenosis in 2 cases, and esophageal perforation in 3 cases. All of these adverse events were treated conservatively without surgical intervention. Of the 331 patients, the depth of tumor invasion was epithelial layer in 109 cases, lamina propria in 155 cases, muscularis mucosa in 9 cases, submucosal layer (<0.2 mm) in 12 cases, and submucosal layer (≥0.2 mm) in 42 cases. Of the 331 pati-ents, there were squamous cell carcinoma in 302 cases and adenocarcinoma in 29 cases. Of the 331 pati-ents, 57 cases had difficulties in ESD. (2)Analysis of Influencing factors associated with difficulty in ESD for early esophageal cancer and precancerous lesions. Results of multivariate analysis showed that esophageal cancer located in the left wall, longitudinal tumor diameter>30 mm, and tumor circumference exceeding half of the esophageal circumference were independent risk factors for difficulty in ESD for early esophageal cancer and precancerous lesions (odds ratio=3.903, 6.699, 5.387, 95% confidence interval as 1.423-10.702, 1.222-36.735, 1.492-19.468, P<0.05).

    Conclusion 

    Esophageal cancer located in the left wall, tumor size greater than 30 mm and tumor circumference exceeding half of the esophageal circumference are independent risk factors for difficulty in ESD for early esophageal cancer and precancerous lesions.

  • 食管癌早期诊断困难,患者预后较差[1]。随着光学成像技术和相关仪器的发展,浅表食管癌早期诊断成为可能。与传统内镜黏膜切除术比较,内镜黏膜下剥离术(endoscopic submucosal dissection,ESD)可对早期食管肿瘤行直接黏膜下剥离,且整块切除率高,有助于病理学准确诊断[2]。由于食管管腔狭窄、壁薄,会随着呼吸和心脏搏动不断移动,食管ESD存在手术时间延长的风险,还可能导致手术失败、穿孔和纵隔气肿等不良事件[3]。了解食管ESD操作难度的影响因素有助于提高其成功率。本研究回顾性分析2011年12月至2021年12月新乡市中心医院收治的331例早期食管癌及癌前病变患者的临床病理资料,探讨早期食管癌及癌前病变ESD操作困难的影响因素。

    采用回顾性病例对照研究方法。收集331例早期食管癌及癌前病变患者的临床病理资料;男229例,女102例;年龄为(72.6±2.7)岁。本研究通过我院医学伦理委员会审批,批号为XX‑ZX‑5012。患者及家属均签署知情同意书。

    纳入标准:(1)年龄为18~85岁。(2)符合《中国食管癌筛查与早诊早治指南(2022,北京)》中早期食管癌及癌前病变的诊断标准[4]。(3)行ESD。(4)术前无感染性疾病。(5)临床资料完整。

    排除标准:(1)合并凝血功能障碍。(2)存在严重的心、肝、肺、脑、肾等器官相关的基础疾病。(3)患有精神疾病,生活不能自理。(4)长期服用抗PLT类药物。

    ESD:根据主刀医师判断,先使用1%碘染料溶液进行色素内镜检查确定病变,使用电外科刀标记病变边缘。将10%甘油溶液和稀释的肾上腺素(1∶200 000)混合后注入黏膜下层,便于将黏膜与肌肉层分离,随后对病变进行环形黏膜切开行黏膜下剥离,整块切除病变。当ESD后发生黏膜缺损超过食管周长3/4时,可局部注射曲安奈德防止术后食管狭窄。

    观察指标:(1)ESD手术情况。(2)早期食管癌及癌前病变ESD操作困难的影响因素分析。

    评价标准:肿瘤位置分为颈段、胸上段、胸中段、胸下段或腹段食管[5]。肿瘤定位分为前壁、后壁、右壁或左壁[5]。食管肿瘤周长以食管周长的比例测量,通过将食管腔分成八等份(例如3/8或6/8)计算[6]。整块切除定义为将所有标记点的病变单个切除[7]。不良事件包括术后出血、食管穿孔和术后食管狭窄[8]。术后出血为ESD后需要输血干预[9]。术后食管狭窄为食管收紧,导致需行球囊扩张治疗[10]。手术时间>120 min或并发穿孔、食管狭窄、纵隔气肿,以及黏膜剥离失败、需更改原黏膜剥离治疗方式或追加其他肿瘤治疗定义为食管ESD困难病例[1112]

    应用SPSS 26.0统计软件进行分析。正态分布的计量资料采用x±s表示,组间比较采用t检验。计数资料以绝对数表示,组间比较采用χ²检验。单因素分析根据资料类型选择对应的统计学方法。以ESD难度为因变量(困难病例=1,非困难病例=0),将单因素分析P<0.05指标的二分类变量及连续变量作为自变量并赋值,ESD操作难度的赋值情况如下:多分类变量中肿瘤部位以颈部、肿瘤定位以前壁为哑变量,肿瘤浸润深度T1b期(是=1,否=0),使用夹线牵引法(是=1,否=0),肿瘤周长与食管周长比>1/2(是=1,否=0),纵向肿瘤长径>30 mm(是=1,否=0),内镜医师经验≤10年(是=1,否=0),将以上因素纳入逐步Logistic回归分析。多因素分析采用Logistic逐步回归模型。P<0.05为差异有统计学意义。

    331例患者手术时间为(67±8)min,整块切除327例、分块切除4例。不良事件:出血1例、纵隔气肿2例、食管狭窄2例、食管穿孔3例,以上患者均采用保守治疗,无需手术。331例患者肿瘤侵犯深度:上皮层109例、黏膜固有层155例、黏膜肌层9例、黏膜下层(<0.2 mm)12例、黏膜下层(≥0.2 mm)42例。331例患者中,鳞状细胞癌302例,腺癌29例。331例患者中,57例为ESD操作困难。

    单因素分析结果显示:肿瘤部位、肿瘤定位、纵向肿瘤长径、肿瘤周长与食管周长比、肿瘤浸润深度、使用夹线牵引法、内镜医师经验是影响早期食管癌及癌前病变ESD操作困难的相关因素(P<0.05),而性别、年龄、BMI、吸烟史、饮酒史、合并高血压病、合并糖尿病、合并高脂血症、合并冠心病、肿瘤大体类型、组织病理学类型不是影响早期食管癌及癌前病变ESD操作困难的相关因素(P>0.05),见表1

    表  1  影响331例早期食管癌及癌前病变患者内镜黏膜下剥离术操作困难的单因素分析
    Table  1.  Univariate analysis of difficulty in endoscopic submucosal dissection in 331 patients of early esophageal cancer and precancerous lesions
    临床病理因素例数非困难操作(274例)困难操作(57例)统计量值P
    性别
    22919138χ²=0.2050.651
    1028319
    年龄(x±s,岁)33169±770±8t=0.6600.510
    体质量指数(x±s,kg/m333123.1±2.623.7±2.4t=1.6670.097
    吸烟史
    13711621χ²=0.5870.444
    19415836
    饮酒史
    16113625χ²=0.6300.427
    17013832
    合并高血压病
    877314χ²=0.1060.745
    24420143
    合并糖尿病
    463511χ²=1.6790.195
    28523946
    合并高脂血症
    786513χ²=0.0220.882
    25320944
    合并冠心病
    49409χ²=0.0530.818
    28223448
    肿瘤部位
    颈部15123χ²=14.7800.005
    胸上段15313217
    胸中段72639
    胸下段755623
    腹部食管16115
    肿瘤定位
    前壁756411χ²=9.4220.024
    后壁998314
    右壁67607
    左壁906725
    肿瘤大体类型
    隆起型877116χ²=0.2950.863
    扁平型60519
    凹陷型18415232
    纵向肿瘤长径(mm)
    ≤3026323132χ²=22.932<0.001
    >30684325
    肿瘤周长与食管周长比
    ≤1/216915514χ²=19.345<0.001
    >1/216211943
    组织病理学类型
    鳞状细胞癌30225151χ²=0.0680.794
    腺癌29236
    肿瘤浸润深度
    T1a期26823528χ²=38.810<0.001
    T1b期633929
    使用夹线牵引法
    836226χ²=12.770<0.001
    23821231
    内镜医师经验
    ≤10年17313538χ²=5.7240.017
    >10年15813919
    下载: 导出CSV 
    | 显示表格

    多因素分析结果显示:食管左壁肿瘤、纵向肿瘤长径>30 mm和肿瘤周长与食管周长比>1/2是早期食管癌及癌前病变ESD操作困难的独立危险因素(P<0.05),见表2

    表  2  影响331例早期食管癌及癌前病变患者内镜黏膜剥离术操作困难的多因素分析
    Table  2.  Multivariate analysis of difficulty in endoscopic submucosal dissection in 331 patients of early esophageal cancer and precancerous lesions
    临床病理因素b标准误Wald优势比95%可信区间P
    食管左壁肿瘤1.3620.5157.0023.9031.423~10.7020.080
    纵向肿瘤长径>30 mm1.6840.6556.6075.3871.492~19.4680.010
    肿瘤周长与食管周长比>1/21.9020.8684.8016.6991.222~36.7350.028
    下载: 导出CSV 
    | 显示表格

    食管癌是上消化道常见的癌症之一,我国食管癌发病率较高,每年死亡人数约15万[13]。早期食管癌患者预后较好,5年生存率≥90%[1415]。ESD是治疗早期食管癌及癌前病变的首选手术方式,不仅能将食管癌前病变完整切除,术后还可提供准确的病理学分期[1617]。然而,食管ESD实践操作有一定难度,ESD困难患者可能导致术后并发症,评估ESD难度是避免并发症的重要解决方案之一[1819]

    本研究中整块切除率、穿孔发生情况与既往研究结果相似[11,20]。ESD困难病例通常需要很长时间,因为操作者需仔细施行黏膜切开和黏膜下剥离过程。以往研究认为手术时间长或并发不良事件是技术难度重要的标志[1112]。本研究将手术时间>120 min或并发穿孔、食管狭窄、纵隔气肿、黏膜剥离失败、需更改原黏膜剥离治疗方式或追加其他肿瘤治疗定义为食管ESD困难病例。

    本研究结果显示:食管左壁病变与ESD难度相关。患者行ESD通常处于左侧卧位,左壁病变处于较深的解剖位置,已剥离的黏膜、血液会干扰黏膜下层的定位,此外由于重力作用,黏膜瓣会留在左侧,很难产生有效的反向牵引。有研究结果显示:夹式牵引可有效提高食管ESD的安全性并有助于缩短手术时间,该方法可对病变施加足够张力,并获得更好的操作视野和更多的黏膜下组织空间,有助于提高食管ESD的适用性[21]。纵向肿瘤长径>30 mm和肿瘤周长与食管周长比>1/2也是导致ESD难度增加的独立危险因素。有研究结果显示:肿瘤长径>30 mm、肿瘤位于胸下段食管、肿瘤周长超过管腔一半可能引发并发症[22]。另有研究结果显示:ESD难度增加是造成食管周围黏膜缺损面积太大的重要因素,食管肿瘤周长与管腔2/3的患者术后食管狭窄发生率为70.1%[23]。因此,对于肿瘤缺损大的患者需要特别注意黏膜剥离过程。然而,其他因素也会导致食管ESD困难,例如术中出血、无法抬起食管以及蠕动导致的视野不稳定[24]

    本研究局限性:(1)回顾性研究易受选择偏倚和回忆偏差的影响。(2)研究队列相对较小且为单中心研究。

    综上,食管左壁肿瘤、纵向肿瘤长径>30 mm和肿瘤周长与食管周长比>1/2是早期食管癌及癌前病变行ESD困难的独立危险因素。

    薛然荣:研究设计,实施研究,文章撰写;沈裕厚:采集数据和统计分析;方晓霞:支持性贡献;孙明明:数据分析和解释
    所有作者均声明不存在利益冲突
    薛然荣, 沈裕厚, 方晓霞, 等. 早期食管癌及癌前病变内镜黏膜下剥离术操作困难的影响因素分析[J]. 中华消化外科杂志, 2024, 23(10): 1326-1331. DOI: 10.3760/cma.j.cn115610-20240920-00425.
    http://journal.yiigle.com/LinkIn.do?linkin_type=cma&DOI=10.3760/cma.j.cn115610-20240920-24425
  • 表  1   影响331例早期食管癌及癌前病变患者内镜黏膜下剥离术操作困难的单因素分析

    Table  1   Univariate analysis of difficulty in endoscopic submucosal dissection in 331 patients of early esophageal cancer and precancerous lesions

    临床病理因素例数非困难操作(274例)困难操作(57例)统计量值P
    性别
    22919138χ²=0.2050.651
    1028319
    年龄(x±s,岁)33169±770±8t=0.6600.510
    体质量指数(x±s,kg/m333123.1±2.623.7±2.4t=1.6670.097
    吸烟史
    13711621χ²=0.5870.444
    19415836
    饮酒史
    16113625χ²=0.6300.427
    17013832
    合并高血压病
    877314χ²=0.1060.745
    24420143
    合并糖尿病
    463511χ²=1.6790.195
    28523946
    合并高脂血症
    786513χ²=0.0220.882
    25320944
    合并冠心病
    49409χ²=0.0530.818
    28223448
    肿瘤部位
    颈部15123χ²=14.7800.005
    胸上段15313217
    胸中段72639
    胸下段755623
    腹部食管16115
    肿瘤定位
    前壁756411χ²=9.4220.024
    后壁998314
    右壁67607
    左壁906725
    肿瘤大体类型
    隆起型877116χ²=0.2950.863
    扁平型60519
    凹陷型18415232
    纵向肿瘤长径(mm)
    ≤3026323132χ²=22.932<0.001
    >30684325
    肿瘤周长与食管周长比
    ≤1/216915514χ²=19.345<0.001
    >1/216211943
    组织病理学类型
    鳞状细胞癌30225151χ²=0.0680.794
    腺癌29236
    肿瘤浸润深度
    T1a期26823528χ²=38.810<0.001
    T1b期633929
    使用夹线牵引法
    836226χ²=12.770<0.001
    23821231
    内镜医师经验
    ≤10年17313538χ²=5.7240.017
    >10年15813919
    下载: 导出CSV

    表  2   影响331例早期食管癌及癌前病变患者内镜黏膜剥离术操作困难的多因素分析

    Table  2   Multivariate analysis of difficulty in endoscopic submucosal dissection in 331 patients of early esophageal cancer and precancerous lesions

    临床病理因素b标准误Wald优势比95%可信区间P
    食管左壁肿瘤1.3620.5157.0023.9031.423~10.7020.080
    纵向肿瘤长径>30 mm1.6840.6556.6075.3871.492~19.4680.010
    肿瘤周长与食管周长比>1/21.9020.8684.8016.6991.222~36.7350.028
    下载: 导出CSV
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  • 收稿日期:  2024-09-19
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