Mari Giulio, Santambrogio Gaia, Crippa Jacopo, Cirocchi Roberto, Origi Matteo, Achilli Pietro, Ferrari Giovanni, Megna Stefano, Desio Matteo, Cocozza Eugenio, Maggioni Dario, Montroni Isacco, Spinelli Antonino, Zuliani Walter, Costanzi Andrea, Crestale Sara, Petri Roberto, Bicelli Noemi, Pedrazzani Corrado, Boccolini Andrea, Taffurelli Giovanni, Fingerhut Abe
Colorectal Surgery Unit ASST Brianza, DesioHospital, Desio, Italy.
University of Milan, Milan, Italy.
Eur J Surg Oncol. 2023 Mar;49(3):641-646. doi: 10.1016/j.ejso.2022.10.017. Epub 2022 Oct 28.
The oncological outcomes of low ligation (LL) compared to high ligation (HL) of the inferior mesenteric artery (IMA) during low-anterior rectal resection (LAR) with total mesorectal excision are still debated. The aim of this study is to report the 5 year oncologic outcomes of patients undergoing laparoscopic LAR with either HL vs. LL of the IMA MATERIALS AND METHODS: Between June 2014 and December 2016, patients who underwent elective laparoscopic LAR + TME in 6 Italian non-academic hospitals were randomized to HL or LL of IMA after meeting the inclusion criteria (HighLow trial; ClinicalTrials.gov Identifier NCT02153801). We analyzed the rate of local recurrence, distant metastasis, overall survival, disease-specific survival, and disease-free survival at 5 years of patients previously enrolled.
Five-year follow up data were available for 196 patients. Recurrence happened in 42 (21.4%) of patients. There was no statistically significant difference in the distant recurrence rate (15.8% HL vs. 18.9% LL; P = 0.970) and pelvic recurrence rate (4,9% HL vs 3,2% LL; P = 0.843). No statistically significant difference was found in 5-year OS (p = 0.545), DSS (p = 0.732) or DFS (p = 0.985) between HL and LL. Low vs medium and upper rectum site of tumor, conversion rate, Clavien-Dindo post-operative grade ≥3 complications and tumor stage were found statistically significantly associated to poor oncological outcomes in univariate analysis; in multivariate analysis, however, only conversion rate and stage 3 cancer were found to be independent risk factors for poor DFS at 5 years.
We confirmed the results found in the previous 3-year survival analysis, the level of inferior mesenteric artery ligation does not affect OS, DSS and DFS at 5-year follow-up.
在低位直肠癌前切除术（LAR）中，与肠系膜下动脉（IMA）高位结扎（HL）相比，低位结扎（LL）的肿瘤学结局仍存在争议。本研究的目的是报告接受IMA高位结扎与低位结扎的腹腔镜LAR患者的5年肿瘤学结局。材料与方法：2014年6月至2016年12月期间，在6家意大利非学术医院接受择期腹腔镜LAR + TME的患者在符合纳入标准后被随机分为IMA高位结扎组或低位结扎组（HighLow试验；ClinicalTrials.gov标识符NCT02153801）。我们分析了先前入组患者5年时的局部复发率、远处转移率、总生存率、疾病特异性生存率和无病生存率。
196例患者有5年随访数据。42例（21.4%）患者出现复发。远处复发率（HL组15.8% vs. LL组18.9%；P = 0.970）和盆腔复发率（HL组4.9% vs. LL组3.2%；P = 0.843）无统计学显著差异。HL组和LL组之间在5年总生存率（p = 0.545）、疾病特异性生存率（p = 0.732）或无病生存率（p = 0.985）方面均未发现统计学显著差异。在单因素分析中，肿瘤位于低位与中位及高位直肠部位、转化率、Clavien-Dindo术后≥3级并发症和肿瘤分期与不良肿瘤学结局有统计学显著相关性；然而，在多因素分析中，仅转化率和3期癌症被发现是5年无病生存率差的独立危险因素。
我们证实了先前3年生存分析的结果，肠系膜下动脉结扎水平在5年随访时不影响总生存率、疾病特异性生存率和无病生存率。
