中国taTME病例登记协作研究数据库中直肠癌经括约肌间切除术标本质量分析:一项全国性登记研究

Analysis of specimen quality of intersphincteric resection for rectal cancer in the Chinese Transanal Total Mesorectal Excision Registry Collaborative database:a nationwide registered study

目的探讨中国经肛全直肠系膜切除术病例登记协作研究(CTRC)数据库中直肠癌经腹经肛混合入路括约肌间切除术(ISR)标本质量。方法采用回顾性病例对照研究方法。基于真实世界研究理念,收集2017年11月15日至2023年12月31日CTRC数据库中首都医科大学附属北京友谊医院等19家医学中心收治的281例直肠癌行经腹经肛混合入路ISR患者的临床病理资料;男196例,女85例;年龄为61(27~87)岁。观察指标:(1)术前检查情况;(2)新辅助治疗情况;(3)术后检查情况;(4)直肠癌ISR标本环周切缘阳性的影响因素分析。正态分布的计量资料以x±s表示,偏态分布的计量资料以M(范围)表示。计数资料以绝对数或百分比表示。单因素分析采用χ^(2)检验。多因素分析采用Logistic回归模型。结果(1)术前检查情况。281例患者中,234例行术前盆腔磁共振成像(MRI)检查,其中临床T0期2例、T1期3例、T2期58例、T3期137例、T4期24例、Tx期3例,数据缺失7例;临床N0期87例、N1期68例、N2期60例、Nx期9例,数据缺失10例;30例直肠系膜筋膜阳性;53例壁外血管侵犯阳性;肿瘤下缘距肛缘距离为41.9(1.0~80.0)mm。(2)新辅助治疗情况。281例患者中,125例行新辅助治疗,其中单纯化疗39例、短程同步放化疗6例、短程同步放化疗+延迟手术5例、长程同步放化疗48例、其他方案2例,数据缺失25例。(3)术后检查情况。281例患者中,R_(0)切除、R_(1)切除分别为249、9例,数据缺失23例;肿瘤最大径为30.0(0.5~200.0)mm,获取淋巴结数目为13(0~70)枚,脉管内瘤栓阳性率为27.55%(73/265);252例记录环周切缘情况,环周切缘阳性15例,切缘阳性率为5.95%(15/252),肿瘤深部距环周切缘最小距离为7.0(0~150.0)mm;85例记录远端切缘情况,远端切缘阳性1例,肿瘤下缘距远端切缘距离为10.0(0~202.0)mm;273例记录标本完整性情况,标本质量完好、一般、不佳、未评估分别为208、58、4、3例;7例发生肠管穿孔。281例患者中,病理学T0期、Tis期、T1期、T2期、T3期、T4期分别为14、5、22、107、113、12例,数据缺失8例;病理学N0期、N1a期、N1b期、N1c期、N2a期、N2b期分别为176、27、27、11、20、12例,数据缺失8例;有远处转移4例,无远处转移262例,无法评估5例,数据缺失10例。125例行新辅助治疗患者中,85例记录标本肿瘤退缩分级情况,其中肿瘤退缩分级1级、2级、3级、4级、5级分别为16、27、19、15、8例。(4)直肠癌ISR标本环周切缘阳性的影响因素分析。单因素分析结果显示:术前盆腔MRI检查T分期、直肠系膜筋膜、壁外血管侵犯、病理学T分期、病理学N分期是影响直肠癌ISR标本环周切缘阳性的相关因素(P<0.05)。结论经腹经肛混合入路ISR的直肠癌手术标本质量好、切缘阳性率低。术前盆腔MRI检查T分期与直肠癌ISR标本环周切缘阳性相关。

Objective To investigate the specimen quality of intersphincteric resection with transabdominal transanal mixed approach for rectal cancer in the Chinese Transanal Total Mesorectal Excision Registry Collaborative(CTRC)database.Methods The retrospective case-control study was conducted.Based on the concept of real-world research,the clinicopathological data of 281 patients with rectal cancer in the CTRC database who underwent intersphincteric resection with trans-abdominal transanal mixed approach in 19 medical centers,including the Beijing Friendship Hospital of Capital Medical University etal,from November 15,2017 to December 31,2023 were collected.There were 196 males and 85 females,aged 61(range,27-87)years.Observation indicators:(1)preoperative examinations;(2)neoadjuvant therapy;(3)postoperative examinations;(4)analysis of influencing factors for positive circumferential margin in surgical specimen of intersphincteric resec-tion for rectal cancer.Measurement data with normal distribution were represented as Mean±SD.Measurement data with skewed distribution were represented as M(range).Count data were described as absolute numbers or percentages.The chi-square test was used for univariate analysis.Logistic regression model was used for multivariate analysis.Results(1)Preoperative examinations.Of the 281 patients,234 cases underwent preoperative pelvic magnetic resonance imaging(MRI)examina-tion.There were 2 cases in clinical stage T0,3 cases in clinical stage T1,58 cases in clinical stage T2,137 cases in clinical stage T3,24 cases in clinical stage T4,3 cases in clinical stage Tx,7 cases missing clinical T staging data.There were 87 cases in clinical stage N0,68 cases in clinical stage N1,60 cases in clinical stage N2,9 cases in clinical stage Nx,10 cases missing clinical N staging data.There were 30 cases with mesorectal fascia invasion,53 cases with extramural venous invasion.The distance from lower margin of tumor to anal margin was 41.9(range,1.0-80.0)mm.(2)Neoadjuvant therapy.Of the 281 patients,125 cases underwent neoadjuvant therapy,including 39 cases receiving chemo-therapy alone,6 cases receiving short-course simultaneous chemoradiotherapy,5 cases receiving short-course simultaneous chemoradiotherapy and delayed surgery,48 cases receiving long-course simultaneous chemoradiotherapy,2 cases receiving other treatments,and 25 cases missing neoadju-vant therapy data.(3)Postoperative examinations.Of the 281 patients,249 cases achieved R_(0) resection,9 cases achieved R_(1) resection,and there were 23 cases missing surgical margin data.The maximum tumor diameter,the number of lymph nodes harvested and positive rate of vessel carcinoma embolus were 30.0(range,0.5-200.0)mm,13(range,0-70)and 27.55%(73/265)in 281 patients.There were 252 patients with circumferential margin records,showing positive in 15 cases,with a positive rate as 5.95%(15/252).The minimum distance from deep part of tumor to circumferential margin was 7.0(range,0-150.0)mm in 252 patients.There were 85 cases with distal margin records,showing positive in 1 case,and the distance from lower margin of tumor to distal margin was 10.0(range,0-202.0)mm.There were 273 patients with specimen integrity records,which showed intact specimen in 208 cases,fair specimen in 58 cases,poor specimen in 4 cases,unevaluated specimen in 3 cases.There were 7 cases with rectal perforation.Of the 281 patients,cases in pathological stage T0,Tis,T1,T2,T3,T4 were 14,5,22,107,113,12,respectively,and there were 8 cases missing pathological T staging data.Of the 281 patients,cases in pathological stage N0,N1a,N1b,N1c,N2a,N2b were 176,27,27,11,20,12,respectively,and there were 8 cases missing pathological N staging data.Of the 281 patients,there were 4 cases with distant metastasis,262 cases without distant metastasis,5 cases not evaluated,and 10 cases missing tumor metastasis data.Of the 125 patients undergoing neoadjuvant therapy,there were 85 cases with tumor regression grade records,including 16 cases as grade 1,27 cases as grade 2,19 cases as grade 3,15 cases as grade 4,8 cases as grade 5.(4)Analysis of influencing factors for positive circumferential margin in surgical specimen of intersphincteric resection for rectal cancer.Results of univariate analysis showed that preoperative T staging on preoperative pelvic MRI,mesorectal fascia invasion,extramural venous invasion,pathological T staging,and pathological N staging were related factors for positive circumferential margin in surgical specimen of intersphincteric resection for rectal cancer(P<0.05).Conclusions Intersph-incteric resection with transabdominal transanal mixed approach has good specimen quality and low positive rate of surgical margin.T staging on preoperative pelvic MRI may be related to positive circumferential margin after intersphincteric resection for rectal cancer.