Mari Giulio M, Crippa Jacopo, Achilli Pietro, Montroni Isacco, Ugolini Giampaolo, Taffurelli Giovanni, Cocozza Eugenio, Borroni Giacomo, Valenti Francesco, Roscio Francesco, Ferrari Giovanni, Origi Matteo, Zuliani Walter, Pugliese Raffaele, Costanzi Andrea T M, Fingherut Abe, Maggioni Dario
From the Laparoscopic and Oncological General Surgery Department, ASST Monza, Desio Hospital, Desio MB, Italy.
General Surgery Residency Program, University of Milan, Milan, Italy.
Ann Surg Open. 2020 Oct 19;1(2):e017. doi: 10.1097/AS9.0000000000000017. eCollection 2020 Dec.
To determine the disease-free survival (DFS), disease-specific survival (DSS), and recurrence in patients who underwent laparoscopic low anterior rectal resection with total mesorectal excision (TME) with either high or low ligation of the inferior mesenteric artery (IMA).
The level of IMA ligation during anterior rectal resection with TME is still a matter of debate, especially in terms of oncological adequacy.
Between June 2014 and December 2016, patients scheduled to undergo elective laparoscopic low anterior resection (LAR) and TME in 6 Italian nonacademic hospitals were randomized into 2 groups in the HIGHLOW Trial (ClinicalTrials.gov Identifier: NCT02153801) according to the level of IMA ligation: high ligation (HL) versus low ligation (LL). DFS, DSS, and recurrence were inquired. Recurrence was determined at 3, 6, 9, and 12 months and every 6 months thereafter. Patients and tumor characteristics as well as surgical outcomes were analyzed to identify risk factors for recurrence.
One hundred ninety-six patients from the HIGHLOW trial were analyzed. Median follow-up for DFS was 40.6 (interquartile range [IQR], 6-64.7) and 40 (IQR, 7.6-67.8), while median follow-up for DSS was 41.2 (IQR, 10.7-64.7) and 42.7 (IQR, 6-67.6) in the HL and LL groups, respectively. The 3-year DFS rate of HL and LL patients was 82.2% and 82.1% ( = 0.874), respectively. The 3-year DSS for HL and LL patients was 92.1% and 93.4% ( = 0.897), respectively. There was no statistically significant difference in the local recurrence rate (2% HL vs 2.1% LL), in the regional recurrence rate (3% HL vs 2.1% LL), and in the distant recurrence rate (12.9% HL vs 13.7% LL). Multivariate analysis found conversion to open surgery (hazard ratio [HR], 3.68; = 0.001) and higher stage of disease (HR, 7.73; < 0.001) to be significant determinant for DFS.
The level of inferior mesenteric artery ligation during LAR and TME for rectal cancer does not affect DFS, DSS, and recurrence.
确定接受腹腔镜低位前直肠切除术并完整系膜切除（TME）且肠系膜下动脉（IMA）高位或低位结扎的患者的无病生存期（DFS）、疾病特异性生存期（DSS）和复发情况。
在TME直肠前切除术中IMA结扎水平仍存在争议，尤其是在肿瘤学充分性方面。
在2014年6月至2016年12月期间，6家意大利非学术医院计划接受择期腹腔镜低位前切除术（LAR）和TME的患者在HIGHLOW试验（ClinicalTrials.gov标识符：NCT02153801）中根据IMA结扎水平随机分为2组：高位结扎（HL）组与低位结扎（LL）组。询问DFS、DSS和复发情况。在3、6、9和12个月以及此后每6个月确定复发情况。分析患者和肿瘤特征以及手术结果以确定复发的危险因素。
对HIGHLOW试验中的196例患者进行了分析。HL组和LL组DFS的中位随访时间分别为40.6（四分位间距[IQR]，6 - 64.7）和40（IQR，7.6 - 67.8），而DSS的中位随访时间分别为41.2（IQR，10.7 - 64.7）和42.7（IQR，6 - 67.6）。HL组和LL组患者的3年DFS率分别为82.2%和82.1%（P = 0.874）。HL组和LL组患者的3年DSS分别为92.1%和93.4%（P = 0.897）。局部复发率（HL组为2% vs LL组为2.1%）、区域复发率（HL组为3% vs LL组为2.1%）和远处复发率（HL组为12.9% vs LL组为13.7%）均无统计学显著差异。多因素分析发现转为开放手术（风险比[HR]，3.68；P = 0.001）和疾病分期较高（HR，7.73；P < 0.001）是DFS的重要决定因素。
直肠癌LAR和TME术中肠系膜下动脉结扎水平不影响DFS、DSS和复发。
