中国经肛全直肠系膜切除手术病例登记协作研究数据库2018年度报告:一项全国性登记研究
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摘要
目的介绍并评估基于全国性登记系统经肛全直肠系膜切除(TaTME)手术病例的术后短期临床病理学疗效。方法基于真实世界研究的理念,通过回顾性及前瞻性收集并分析2017-11-15至2018-06-30来自全国性、多中心登记录入中国TaTME病例登记协作研究数据库(CTRC)的601例TaTME手术病例,评估TaTME手术的安全性、有效性。结果 (1)601例中男性病人占68.7%,年龄为(59.5±11.4)岁,BMI为23.9±3.6;其中有558例为直肠癌病人,直肠肿瘤下缘距肛缘的平均距离为(48.1±14.8)mm,直肠癌病人接受新辅助治疗的比例为31.7%。(2)24.6%的直肠癌手术病例是在专家指导下完成,出血量为(115.2±366.5)mL,手术时间为(247.1±87.5)min,使用吻合器吻合占74.8%,施行预防造口的比例为49.6%,不稳定的盆腔CO_2灌注压力、盆腔术野烟雾为最常见的术中困难;术者对直肠癌病人TaTME手术标本系膜完整性评估为完整、近乎完整、不完整的比例分别为79.6%、16.8%、0.2%。(3)直肠癌病人术后并发症发生率为20.2%,吻合口漏发生率为7.0%。(4)共有8例标本发生穿孔,淋巴结检出数目为(15.4±7.9)枚。结论术后短期的临床病理学结果显示,TaTME手术安全有效,能够保证下端直肠系膜切除的完整性、环周切缘以及远端切缘的安全性。然而,CTRC数据质量仍须改善,TaTME手术的结构化培训不可或缺,尚须进一步的全国性多中心前瞻性临床试验评价TaTME手术与TME手术的疗效差别。
Objective to introduce the study method of Chinese Transanal Total Mesorectal Excision(TaTME) registry Collaborative(CTRC),and report the short-term clinical-oncological outcomes from CTRC. Methods Based upon the concept of real world evidence,Data of 601 cases were retrospectively and prospectively analyzed from a nationwide multi-center registry system of CTRC.The safety and effectiveness of these cases were evaluated. Results The results of the CTRC database showed that:(1) 68.7% of 601 patients were male,the average age of all patients was(59.5±11.4)years,the average BMI was 23.9±3.6. There were 558 cases of rectal cancer among the total enrolled cases. The average distance between the distal edge of rectal cancer and the anal verge was(48.1±14.8)mm,and the ratio of neoadjuvant therapy was 31.7%.(2) 24.6% of the surgical cases were completed under the supervision of TaTME experts. The mean volume of intraoperative blood loss was(115.2 ± 366.5)mL,and the mean operating time was(247.1±87.5)min. Circle stapler was used to make the anastomosis among 74.8% of rectal cancer cases. The protective stoma was performed among 49.6% of the cases of rectal cancer. Maintaining a stable pneumopelvis and excessive smoke obscuring the pelvic view,were the main intraoperative difficulties encountered during transanal procedure. According to the grading of quality and completeness of the mesorectum in the total mesorectal excision specimen,the incidence rates of TaTME specimen graded as "complete", "nearly complete" and "incomplete" were79.6%,16.8% and 0.2% respectively by the evaluation of surgeons.(3)The incidence of postoperative complications was20.2%,and the anastomotic leakage rate was 7.0%.(4) There were 8 cases of specimen perforation. The average number of lymph node harvest was 15.4±7.9. Conclusion TaTME procedure seems be safe and effective regarding to the shortterm clinical-pathological outcomes. The completeness of distal mesorectal dissection,circumferential resection margin and distal resection margin can be promised by the procedure of TaTME. However,the data quality in the database of CTRC needs to be improved,and structured training for TaTME surgery is indispensable. Further national multicenter prospective clinical trials are needed to evaluate the efficacy of TaTME versus TME.
Objective to introduce the study method of Chinese Transanal Total Mesorectal Excision(TaTME) registry Collaborative(CTRC),and report the short-term clinical-oncological outcomes from CTRC. Methods Based upon the concept of real world evidence,Data of 601 cases were retrospectively and prospectively analyzed from a nationwide multi-center registry system of CTRC.The safety and effectiveness of these cases were evaluated. Results The results of the CTRC database showed that:(1) 68.7% of 601 patients were male,the average age of all patients was(59.5±11.4)years,the average BMI was 23.9±3.6. There were 558 cases of rectal cancer among the total enrolled cases. The average distance between the distal edge of rectal cancer and the anal verge was(48.1±14.8)mm,and the ratio of neoadjuvant therapy was 31.7%.(2) 24.6% of the surgical cases were completed under the supervision of TaTME experts. The mean volume of intraoperative blood loss was(115.2 ± 366.5)mL,and the mean operating time was(247.1±87.5)min. Circle stapler was used to make the anastomosis among 74.8% of rectal cancer cases. The protective stoma was performed among 49.6% of the cases of rectal cancer. Maintaining a stable pneumopelvis and excessive smoke obscuring the pelvic view,were the main intraoperative difficulties encountered during transanal procedure. According to the grading of quality and completeness of the mesorectum in the total mesorectal excision specimen,the incidence rates of TaTME specimen graded as "complete", "nearly complete" and "incomplete" were79.6%,16.8% and 0.2% respectively by the evaluation of surgeons.(3)The incidence of postoperative complications was20.2%,and the anastomotic leakage rate was 7.0%.(4) There were 8 cases of specimen perforation. The average number of lymph node harvest was 15.4±7.9. Conclusion TaTME procedure seems be safe and effective regarding to the shortterm clinical-pathological outcomes. The completeness of distal mesorectal dissection,circumferential resection margin and distal resection margin can be promised by the procedure of TaTME. However,the data quality in the database of CTRC needs to be improved,and structured training for TaTME surgery is indispensable. Further national multicenter prospective clinical trials are needed to evaluate the efficacy of TaTME versus TME.
引文
[1]Sylla P,Rattner DW,Delgado S,et al.NOTES transanal rectal cancer resection using transanal endoscopic microsurgery and laparoscopic assistance[J].Surg Endosc,2010,24(5):1205-1210.
[2]陈远光,胡明,雷建,等.经肛内镜全直肠系膜切除治疗直肠癌[J].中国内镜杂志,2010,16(12):1261-1265.
[3]张浩,张云生,金雄伟,等.完全经肛单孔腹腔镜全直肠系膜切除术治疗直肠癌[J].中国内镜杂志,2012,18(4):379-383.
[4]Zhang H,Zhang YS,Jin XW,et al.Transanal single-port laparoscopic total mesorectal excision in the treatment of rectal cancer[J].Tech Coloproctol,2013,17(1):117-123.
[5]Lacy AM,Rattner DW,Adelsdorfer C,et al.Transanal natural orifice transluminal endoscopic surgery(NOTES)rectal resection:“down-to-up”total mesorectal excision(TME)--shortterm outcomes in the first 20 cases[J].Surg Endosc,2013,27(9):3165-3172.
[6]Leroy J,Barry BD,Melani A,et al.No-scar transanal total mesorectal excision:the last step to pure NOTES for colorectal surgery[J].JAMA Surg,2013,148(3):226-230.
[7]Atallah S,Martin-Perez B,Pinan J,et al.Robotic transanal total mesorectal excision:a pilot study[J].Tech Coloproctol,2014,18(11):1047-1053
[8]Fernández-Hevia M,Delgado S,Castells A,et al.Transanal total mesorectal excision in rectal cancer:short-term outcomes in comparison with laparoscopic surgery[J].Ann Surg,2015,261(2):221-227.
[9]Cahill RA,Hompes R.Transanal total mesorectal excision[J].Br J Surg,2015,102(13):1591-1593.
[10]Chen WH,Kang L,Luo SL,et al.Transanal total mesorectal excision assisted by single-port laparoscopic surgery for low rectal cancer[J].Tech Coloproctol,2015,19(9):527-534.
[11]Atallah S,Martin-Perez B,Parra-Davila E,et al.Robotic transanal surgery for local excision of rectal neoplasia,transanal total mesorectal excision,and repair of complex fistulae:clinical experience with the first 18 cases at a single institution[J].Tech Coloproctol,2015,19(7):401-410.
[12]Veltcamp Helbach M,Deijen CL,Velthuis S,et al.Transanal total mesorectal excision for rectal carcinoma:short-term outcomes and experience after 80 cases[J].Surg Endosc,2016,30(2):464-470.
[13]Chen CC,Lai YL,Jiang JK,et al.Transanal Total Mesorectal Excision Versus Laparoscopic Surgery for Rectal Cancer Receiving Neoadjuvant Chemoradiation:A Matched Case-Control Study[J].Ann Surg Oncol,2016,23(4):1169-1176.
[14]Marks JH,Montenegro GA,Salem JF,et al.Transanal TATA/TME:a case-matched study of ta TME versus laparoscopic TME surgery for rectal cancer[J].Tech Coloproctol,2016,20(7):467-473.
[15]Kang L,Chen WH,Luo SL,et al.Transanal total mesorectal excision for rectal cancer:a preliminary report[J].Surg Endosc,2016,30(6):2552-2562.
[16]杨盈赤,金岚,张忠涛.完全经肛门全直肠系膜切除8例报告[J].中国实用外科杂志,2015,35(8):850-856.
[17]邱辉忠,肖毅,徐徕,等.经肛门内镜联合腹腔镜全直肠系膜切除治疗低位直肠癌的安全性和可行性[J].中华胃肠外科杂志,2016,19(1):41-44.
[18]Yao HW,Wu GC,Yang YC,et al.Laparoscopic-assisted transanal total mesorectal excision for middle-low rectal carcinoma:A clinical study of 19 cases[J].Anticancer Res,2017,37(8):4599-4604.
[19]Law WL,Foo DCC.Comparison of early experience of robotic and transanal total mesorectal excision using propensity score matching[J].Surg Endosc,2018 Jul 16.doi:10.1007/s00464-018-6340-8.[Epub ahead of print].
[20]Penna M,Hompes R,Arnold S,et al.Ta TME registry collaborative.Transanal total mesorectal excision:International registry results of the first 720 cases[J].Ann Surg,2017,266(1):111-117.
[21]Marks JH,Myers EA,Zeger EL,et al.Long-term outcomes by a transanal approach to total mesorectal excision for rectal cancer[J].Surg Endosc,2017,31(12):5248-5257.
[22]Penna M,Hompes R,Arnold S,et al.Incidence and risk factors for anastomotic failure in 1594 patients treated by transanal total mesorectal excision:Results from the international Ta TMEregistry[J].Ann Surg,2018 Jan 5.[Epub ahead of print].
[23]中华医学会外科学分会结直肠外科学组.中国经肛全直肠系膜切除术(Ta TME)病例登记协作研究网络系统2018年报[R].沈阳:2018年中华医学会外科学分会第十三届全国结直肠外科学术会议,2018年.
[24]Heald RJ,Husband EM,Ryall RD.The mesorectum in rectal cancer surgery:the clue to pelvic recurrence?[J].Br J Surg,1982,69(10):613-616.
[25]中华医学会外科学分会结直肠外科学组,中华医学会外科学分会腹腔镜与内镜外科学组.直肠癌经肛全直肠系膜切除专家共识及手术操作指南(2017版)[J].中国实用外科杂志,2017,37(9):978-984
[26]Heald RJ.A new solution to some old problems:transanal TME[J].Tech Coloproctol,2013,17(3):257-258.
[27]Deijen C L,Velthuis S,Tsai A,et al.COLORⅢ:a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer[J].Surg Endosc,2016,30(8):3210-3215.
[28]Francis N,Penna M,Mackenzie H,et al.Consensus on structured training curriculum for transanal total mesorectal excision(Ta TME)[J].Surg Endosc,2017,31(7):2711-2719.
[29]Koedam T W A,Veltcamp Helbach M,Van De Ven P M,et al.Transanal total mesorectal excision for rectal cancer:evaluation of the learning curve[J].Tech Coloproctol,2018,22(4):279-287.
[30]Lacy A M,Tasende M M,Delgado S,et al.Transanal total mesorectal excision for rectal cancer:Outcomes after 140 patients[J].J Am Coll Surg,2015,221(2):415-423.
[31]Atallah S,Martin-Perez B,Albert M,et al.Transanal minimally invasive surgery for total mesorectal excision(TAMIS-TME):results and experience with the first 20 patients undergoing curative-intent rectal cancer surgery at a single institution[J].Tech Coloproctol,2014,18(5):473-480.
[32]Veltcamp Helbach M,Deijen C L,Velthuis S,et al.Transanal total mesorectal excision for rectal carcinoma:short-term outcomes and experience after 80 cases[J].Surg Endosc,2016,30(2):464-470.
[2]陈远光,胡明,雷建,等.经肛内镜全直肠系膜切除治疗直肠癌[J].中国内镜杂志,2010,16(12):1261-1265.
[3]张浩,张云生,金雄伟,等.完全经肛单孔腹腔镜全直肠系膜切除术治疗直肠癌[J].中国内镜杂志,2012,18(4):379-383.
[4]Zhang H,Zhang YS,Jin XW,et al.Transanal single-port laparoscopic total mesorectal excision in the treatment of rectal cancer[J].Tech Coloproctol,2013,17(1):117-123.
[5]Lacy AM,Rattner DW,Adelsdorfer C,et al.Transanal natural orifice transluminal endoscopic surgery(NOTES)rectal resection:“down-to-up”total mesorectal excision(TME)--shortterm outcomes in the first 20 cases[J].Surg Endosc,2013,27(9):3165-3172.
[6]Leroy J,Barry BD,Melani A,et al.No-scar transanal total mesorectal excision:the last step to pure NOTES for colorectal surgery[J].JAMA Surg,2013,148(3):226-230.
[7]Atallah S,Martin-Perez B,Pinan J,et al.Robotic transanal total mesorectal excision:a pilot study[J].Tech Coloproctol,2014,18(11):1047-1053
[8]Fernández-Hevia M,Delgado S,Castells A,et al.Transanal total mesorectal excision in rectal cancer:short-term outcomes in comparison with laparoscopic surgery[J].Ann Surg,2015,261(2):221-227.
[9]Cahill RA,Hompes R.Transanal total mesorectal excision[J].Br J Surg,2015,102(13):1591-1593.
[10]Chen WH,Kang L,Luo SL,et al.Transanal total mesorectal excision assisted by single-port laparoscopic surgery for low rectal cancer[J].Tech Coloproctol,2015,19(9):527-534.
[11]Atallah S,Martin-Perez B,Parra-Davila E,et al.Robotic transanal surgery for local excision of rectal neoplasia,transanal total mesorectal excision,and repair of complex fistulae:clinical experience with the first 18 cases at a single institution[J].Tech Coloproctol,2015,19(7):401-410.
[12]Veltcamp Helbach M,Deijen CL,Velthuis S,et al.Transanal total mesorectal excision for rectal carcinoma:short-term outcomes and experience after 80 cases[J].Surg Endosc,2016,30(2):464-470.
[13]Chen CC,Lai YL,Jiang JK,et al.Transanal Total Mesorectal Excision Versus Laparoscopic Surgery for Rectal Cancer Receiving Neoadjuvant Chemoradiation:A Matched Case-Control Study[J].Ann Surg Oncol,2016,23(4):1169-1176.
[14]Marks JH,Montenegro GA,Salem JF,et al.Transanal TATA/TME:a case-matched study of ta TME versus laparoscopic TME surgery for rectal cancer[J].Tech Coloproctol,2016,20(7):467-473.
[15]Kang L,Chen WH,Luo SL,et al.Transanal total mesorectal excision for rectal cancer:a preliminary report[J].Surg Endosc,2016,30(6):2552-2562.
[16]杨盈赤,金岚,张忠涛.完全经肛门全直肠系膜切除8例报告[J].中国实用外科杂志,2015,35(8):850-856.
[17]邱辉忠,肖毅,徐徕,等.经肛门内镜联合腹腔镜全直肠系膜切除治疗低位直肠癌的安全性和可行性[J].中华胃肠外科杂志,2016,19(1):41-44.
[18]Yao HW,Wu GC,Yang YC,et al.Laparoscopic-assisted transanal total mesorectal excision for middle-low rectal carcinoma:A clinical study of 19 cases[J].Anticancer Res,2017,37(8):4599-4604.
[19]Law WL,Foo DCC.Comparison of early experience of robotic and transanal total mesorectal excision using propensity score matching[J].Surg Endosc,2018 Jul 16.doi:10.1007/s00464-018-6340-8.[Epub ahead of print].
[20]Penna M,Hompes R,Arnold S,et al.Ta TME registry collaborative.Transanal total mesorectal excision:International registry results of the first 720 cases[J].Ann Surg,2017,266(1):111-117.
[21]Marks JH,Myers EA,Zeger EL,et al.Long-term outcomes by a transanal approach to total mesorectal excision for rectal cancer[J].Surg Endosc,2017,31(12):5248-5257.
[22]Penna M,Hompes R,Arnold S,et al.Incidence and risk factors for anastomotic failure in 1594 patients treated by transanal total mesorectal excision:Results from the international Ta TMEregistry[J].Ann Surg,2018 Jan 5.[Epub ahead of print].
[23]中华医学会外科学分会结直肠外科学组.中国经肛全直肠系膜切除术(Ta TME)病例登记协作研究网络系统2018年报[R].沈阳:2018年中华医学会外科学分会第十三届全国结直肠外科学术会议,2018年.
[24]Heald RJ,Husband EM,Ryall RD.The mesorectum in rectal cancer surgery:the clue to pelvic recurrence?[J].Br J Surg,1982,69(10):613-616.
[25]中华医学会外科学分会结直肠外科学组,中华医学会外科学分会腹腔镜与内镜外科学组.直肠癌经肛全直肠系膜切除专家共识及手术操作指南(2017版)[J].中国实用外科杂志,2017,37(9):978-984
[26]Heald RJ.A new solution to some old problems:transanal TME[J].Tech Coloproctol,2013,17(3):257-258.
[27]Deijen C L,Velthuis S,Tsai A,et al.COLORⅢ:a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer[J].Surg Endosc,2016,30(8):3210-3215.
[28]Francis N,Penna M,Mackenzie H,et al.Consensus on structured training curriculum for transanal total mesorectal excision(Ta TME)[J].Surg Endosc,2017,31(7):2711-2719.
[29]Koedam T W A,Veltcamp Helbach M,Van De Ven P M,et al.Transanal total mesorectal excision for rectal cancer:evaluation of the learning curve[J].Tech Coloproctol,2018,22(4):279-287.
[30]Lacy A M,Tasende M M,Delgado S,et al.Transanal total mesorectal excision for rectal cancer:Outcomes after 140 patients[J].J Am Coll Surg,2015,221(2):415-423.
[31]Atallah S,Martin-Perez B,Albert M,et al.Transanal minimally invasive surgery for total mesorectal excision(TAMIS-TME):results and experience with the first 20 patients undergoing curative-intent rectal cancer surgery at a single institution[J].Tech Coloproctol,2014,18(5):473-480.
[32]Veltcamp Helbach M,Deijen C L,Velthuis S,et al.Transanal total mesorectal excision for rectal carcinoma:short-term outcomes and experience after 80 cases[J].Surg Endosc,2016,30(2):464-470.