中国taTME病例登记协作研究数据库中直肠癌手术标本质量分析:一项全国性登记研究

Quality analysis of surgical specimens of rectal cancer in the Chinese taTME registry collaborative database:a nationwide registered study

目的分析中国经肛全直肠系膜切除术(taTME)病例登记协作研究(CTRC)数据库中直肠癌手术标本质量。方法采用回顾性描述性研究方法。基于真实世界研究理念,收集2017年11月15日至2022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40家医学中心收治的1761例直肠癌行taTME患者的临床病理资料;男1212例,女549例;年龄为62(53~68)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。偏态分布的计量资料以M(范围)表示。计数资料以绝对数表示。结果(1)术前检查情况。1761例患者中,1324例行术前盆腔磁共振成像(MRI)检查,其中临床T0期4例、T1期30例、T2期250例、T3期828例、T4期141例、Tx期11例,数据缺失60例;临床N0期490例、N1期373例、N2期311例、Nx期86例,数据缺失64例;156例直肠系膜筋膜受侵犯,223例肠壁外血管受侵犯;肿瘤下缘距肛缘距离为50(40~60)mm。(2)新辅助治疗情况。1761例患者中,873例行新辅助治疗,其中单纯放疗17例、单纯化疗155例、短程同步放化疗43例、短程同步放化疗+延迟手术26例、接触放疗1例、长程同步放化疗277例、其他9例,数据缺失345例。(3)术后检查情况。1761例患者中,行R_(0)切除、R_(1)切除、R_(2)切除分别为1584、23、1例,数据缺失153例;肿瘤最大径为30(20~45)mm,获取淋巴结数目为13(10~17)枚,脉管内癌栓阳性率为20.794%(330/1587);1647例记录环周切缘情况,环周切缘阳性51例,肿瘤深部距环周切缘最小距离为5(3~13)mm;547例记录远端切缘情况,远端切缘阳性4例,肿瘤下缘距远端切缘距离为20(10~25)mm。1698例记录标本完整性情况,标本完好、一般、不佳、未评估分别为1436、233、8、21例。20例发生肠管穿孔。1761例患者中,病理学T0期、Tis期、T1期、T2期、T3期、T4期分别为103、23、145、515、712、179例,病理学无法评估4例,数据缺失80例;病理学N0期、N1a期、N1b期、N1c期、N2a期、N2b期分别为1117、189、133、66、109、68例,数据缺失79例;发生远处转移79例,无远处转移1591例,数据缺失91例。行新辅助治疗873例患者中,405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105、142、91、43、24例。结论中国直肠癌taTME手术标本质量好、切缘阳性率低,推荐采用格式化的手术后病理报告,做好手术标本病理报告的质量控制。

Objective To analyze the quality of surgical specimens of rectal cancer in the Chinese transanal total mesorectal excision(taTME)registry collaborative(CTRC)database.Methods The retrospective and descriptive study was conducted.Based on the concept of real‑world research,the clinicopathological data of 1761 patients with rectal cancer in the CTRC database who underwent taTME in 40 medical centers,including the Beijing Friendship Hospital of Capital Medical University et al,from November 15,2017 to December 31,2022 were collected.There were 1212 males and 549 females,aged 62(range,53−68)years.Observation indicators:(1)preoperative examinations;(2)neoadjuvant therapy;(3)postoperative examinations.Measurement data with skewed distribution were represented as M(range).Count data were described as absolute numbers.Results(1)Preoperative examinations.Of the 1761 patients,1324 patients underwent preoperative pelvic magnetic resonance imaging examination,and the results showed that 4 cases as clinical T0 stage,30 cases as clinical T1 stage,250 cases as clinical T2 stage,828 cases as clinical T3 stage,141 cases as clinical T4 stage,11 cases as clinical Tx stage,60 cases missing clinical T staging data,490 cases as clinical N0 stage,373 cases as clinical N1 stage,311 cases as clinical N2 stage,86 cases as clinical Nx stage,64 cases missing clinical N staging data,156 cases with mesorectal fascia invasion,223 cases with extraintestinal blood vessels invasion.The distance from lower margin of tumor to anal margin of 1324 patients was 50(range,40−60)mm.(2)Neoadjuvant therapy.Of the 1761 patients,873 patients underwent neoadjuvant therapy,including 17 cases receiving radiotherapy alone,155 cases receiving chemotherapy alone,43 cases receiving short‑course simultaneous chemoradiotherapy,26 cases receiving short‑course simultaneous chemoradiotherapy and delayed surgery,1 case receiving contact radiotherapy,277 cases receiving long‑course simultaneous chemoradiotherapy,9 cases receiving other treatments,and 345 cases missing neoadjuvant therapy data.(3)Postoperative examinations.Of the 1761 patients,1584 cases achieved R_(0) resection,23 cases achieved R_(1) resection,1 case achieved R_(2) resection,and there were 153 cases missing surgical margin data.The tumor diameter,number of lymph nodes harvest and positive rate of intravascular tumor thrombus were 30(range,20−45)cm,13(range,10−17)and 20.794%(330/1587)in 1761 patients.There were 1647 patients with circumferential margin records,which showed positive in 51 cases,and the minimum distance from deep part of tumor to circumferential margin was 5(rang,3−13)mm in 1647 patients.There were 547 cases with distal margin records,which showed positive in 4 cases,and the distance from lower margin of tumor to distal margin was 20(10−25)mm in 547 cases.There were 1698 patients with specimen integrity records,which showed intact specimen in 1436 cases,fair specimen in 233 cases,poor specimen in 8 cases,unevaluated specimen in 21 cases,and there were 20 cases with rectal tube perforation.Of the 1761 patients,cases as pathological T0 stage,Tis stage,T1 stage,T2 stage,T3 stage,T4 stage was 103,23,145,515,712,179,respectively,and there were 4 cases of pathology that could not be evaluated and 80 cases missing pathological T staging data.Of the 1761 patients,cases as pathological N0 stage,N1a stage,N1b stage,N1c stage,N2a stage,N2b stage was 1117,189,133,66,109,68,respectively,and there were 79 cases missing pathological N staging data.Of the 1761 patients,there were 79 cases with distant metastasis,1591 cases without distant metastasis,and 91 cases without data of tumor metastasis.Of the 873 patients undergoing neoadjuvant therapy,there were 405 patients with tumor regression grade records including 105 cases as grade 1,142 cases as grade 2,91 cases as grade 3,43 cases as grade 4,24 cases as grade 5.Conclusions In China,the quality of surgical specimens of taTME for rectal cancer is good with low positive rate of resection margin.It is recommended that using a formatted postoperative pathological report for good quality control of pathological report of surgical specimen.