Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial.
Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial.
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DOI：
10.1001/jama.2015.10529
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发表时间：
2015-10-06
影响因子：
120.7
通讯作者：
Nelson, Heidi
中科院分区：
文献类型：
--
作者：
Fleshman, James;Branda, Megan;Sargent, Daniel J.;Boller, Anne Marie;George, Virgilio;Abbas, Maher;Peters, Walter R., Jr.;Maun, Dipen;Chang, George;Herline, Alan;Fichera, Alessandro;Mutch, Matthew;Wexner, Steven;Whiteford, Mark;Marks, John;Birnbaum, Elisa;Margolin, David;Larson, David;Marcello, Peter;Posner, Mitchell;Read, Thomas;Monson, John;Wren, Sherry M.;Pisters, Peter W. T.;Nelson, Heidi
关于腹腔镜直肠癌切除术的疗效的证据是不完整的，特别是对于疾病晚期的患者。通过对切除的直肠标本进行大体病理和组织学评价，确定腹腔镜切除是否优于开放切除。一项多中心、平衡、非劣效性随机试验于2008年10月至2013年9月招募患者。该试验由来自美国和加拿大35家机构的有资质的外科医生进行。随机选取486例临床II期或III期肛管边缘12cm范围内的直肠癌患者，在完成腹腔镜或开放切除新辅助治疗后。标准腹腔镜和开放入路由有资质的外科医生进行。评估疗效的主要结果是大于1mm的径向切缘、无肿瘤的远端切缘和直肠系膜全切除的完整性。根据临床相关性估计选择6%的非劣效性裕度。在入选的486例患者中，240例腹腔镜切除术患者和222例开放切除术患者可评估。81.7%的腹腔镜切除病例（95%CI, 76.8% ~ 86.6%）和86.9%的开放式切除病例（95%CI, 82.5% ~ 91.4%）成功切除，不支持非效性（差异为- 5.3%；单侧95%CI， - 10.8% ~∞；P为非效性= 0.41）。患者行下前切除术（76.7%）或腹会阴切除术（23.3%）。11.3%的患者转为开腹切除。腹腔镜切除术的手术时间明显更长（平均266.2 vs 220.6分钟；平均差值45.5分钟；95%CI, 27.7-63.4; P < 0.001）。住院时间（7.3天vs 7.0天；平均差值0.3天；95%CI, - 0.6 ~ 1.1）、30天内再入院（3.3%vs 4.1%；差值- 0.7%;95%CI, - 4.2% ~ 2.7%）和严重并发症（22.5%vs 22.1%；差值0.4%;95%CI, - 4.2% ~ 2.7%）无显著差异。462例手术中直肠系膜切除术标本质量完整（77%），接近完整（16.5%）的病例占93.5%。全组90%的患者桡骨周缘呈阴性（腹腔镜切除87.9%，开放切除92.3%,P = 0.11）。不论手术类型，超过98%的患者远端切缘结果为阴性（P = 0.91）。在II期或III期直肠癌患者中，与开放切除术相比，腹腔镜切除术的使用未能达到病理结果的非劣效性标准。等待临床肿瘤学结果，研究结果不支持在这些患者中使用腹腔镜切除术。clinicaltrials.gov标识符：NCT00726622
Evidence about the efficacy of laparoscopic resection of rectal cancer is incomplete, particularly for patients with more advanced-stage disease. To determine whether laparoscopic resection is noninferior to open resection, as determined by gross pathologic and histologic evaluation of the resected proctectomy specimen. A multicenter, balanced, noninferiority, randomized trial enrolled patients between October 2008 and September 2013. The trial was conducted by credentialed surgeons from 35 institutions in the United States and Canada. A total of 486 patients with clinical stage II or III rectal cancer within 12 cm of the anal verge were randomized after completion of neoadjuvant therapy to laparoscopic or open resection. Standard laparoscopic and open approaches were performed by the credentialed surgeons. The primary outcome assessing efficacy was a composite of circumferential radial margin greater than 1 mm, distal margin without tumor, and completeness of total mesorectal excision. A 6%noninferiority margin was chosen according to clinical relevance estimation. Two hundred forty patients with laparoscopic resection and 222 with open resection were evaluable for analysis of the 486 enrolled. Successful resection occurred in 81.7%of laparoscopic resection cases (95%CI, 76.8%–86.6%) and 86.9%of open resection cases (95%CI, 82.5%–91.4%) and did not support noninferiority (difference, −5.3%; 1-sided 95%CI, −10.8%to ∞; P for noninferiority = .41). Patients underwent low anterior resection (76.7%) or abdominoperineal resection (23.3%). Conversion to open resection occurred in 11.3%of patients. Operative time was significantly longer for laparoscopic resection (mean, 266.2 vs 220.6 minutes; mean difference, 45.5 minutes; 95%CI, 27.7–63.4; P < .001). Length of stay (7.3 vs 7.0 days; mean difference, 0.3 days; 95%CI, −0.6 to 1.1), readmission within 30 days (3.3%vs 4.1%; difference, −0.7%; 95%CI, −4.2%to 2.7%), and severe complications (22.5%vs 22.1%; difference, 0.4%; 95%CI, −4.2%to 2.7%) did not differ significantly. Quality of the total mesorectal excision specimen in 462 operated and analyzed surgeries was complete (77%) and nearly complete (16.5%) in 93.5%of the cases. Negative circumferential radial margin was observed in 90% of the overall group (87.9% laparoscopic resection and 92.3%open resection; P = .11). Distal margin result was negative in more than 98%of patients irrespective of type of surgery (P = .91). Among patients with stage II or III rectal cancer, the use of laparoscopic resection compared with open resection failed to meet the criterion for noninferiority for pathologic outcomes. Pending clinical oncologic outcomes, the findings do not support the use of laparoscopic resection in these patients. clinicaltrials.gov Identifier: NCT00726622
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影响因子：
9
作者：
Porter, GA;Soskolne, CL;Newman, SC
通讯作者：
Newman, SC
影响因子：
168.9
作者：
Quirke, Phil;Steele, Robert;Monson, John;Grieve, Robert;Khanna, Subhash;Couture, Jean;O'Callaghan, Chris;Myint, Arthur Sun;Bessell, Eric;Thompson, Lindsay C.;Parmar, Mahesh;Stephens, Richard J.;Sebag-Montefiore, David
通讯作者：
Sebag-Montefiore, David
影响因子：
45.3
作者：
Nagtegaal, ID;van de Velde, CJH;van Krieken, JHJM
通讯作者：
van Krieken, JHJM
影响因子：
2.2
作者：
Xiong, Binghong;Ma, Li;Cheng, Yong
通讯作者：
Cheng, Yong
影响因子：
3.7
作者：
Martel G;Crawford A;Barkun JS;Boushey RP;Ramsay CR;Fergusson DA
通讯作者：
Fergusson DA