体重指数（BMI）≥25.0kg/m²的患者行腹腔镜胃切除术时，术前计算机断层扫描血管造影与标准评估的短期结局：GISSG20 - 01随机临床试验
Short-term outcomes of preoperative computed tomography angiography versus standard assessment in patients with BMI ≥ 25.0 kg/m undergoing laparoscopic gastrectomy: the GISSG20-01 randomized clinical trial.
作者信息
Meng Cheng, Cao Shougen, Li Leping, Xia Lijian, Chu Xianqun, Jiang Lixin, Wang XinJian, Wang Hao, Huang Shusheng, Duan Quanhong, Sun Zuocheng, He Qingsi, Hui Xizeng, Yang Daogui, Zhang Huanhu, Li Zequn, Liu Xiaodong, Tian Yulong, Sun Yuqi, Li Yu, Jiang Haitao, Niu Zhaojian, Zhang Jian, Zhou Yanbing
机构信息
Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, No. 16 Jiangsu Road, Qingdao, China.
Gastrointestinal Tumor Translational Medicine Research Institute of Qingdao University, Qingdao, China.
出版信息
Gastric Cancer. 2025 Mar;28(2):283-293. doi: 10.1007/s10120-024-01580-9. Epub 2025 Jan 9.
BACKGROUND
Laparoscopic gastrectomy lacks hand-direct tactile sense and has a limited surgical field compared to laparotomy. Apart from textbook classification, there are anatomical variations in the gastric arteries. Laparoscopic gastrectomy presents technical difficulties and necessitates a more comprehensive comprehension of regional anatomy than open surgical procedures. We aimed to compare efficacy and safety of preoperative computed tomography angiography (CTA) associated with surgical decision-making for laparoscopic gastrectomy.
METHODS
The GISSG 20-01 study was a multicenter, open-label, randomized clinical trial. The enrollment criteria mainly included histologically confirmed gastric cancer patients with BMI ≥ 25 kg/m. Eligible patients were randomly assigned to the CTA group or the non-CTA group in a 1:1 ratio. The primary endpoint was the volume of intraoperative blood loss.
RESULTS
Between November 2020 and December 2021, 382 patients were enrolled and randomly assigned. After exclusion of 25 patients, 357 patients were included in the modified intention-to-treat population (179 in the CTA group and 178 in the non-CTA group). The mean intraoperative blood loss (CTA vs non-CTA; 74.2 vs 95.0 mL, P = 0.005) and operation time (215.4 vs 231.2 min, P = 0.004) was significantly lower in the CTA group. Total number of retrieved lymph nodes was similar in two groups (32.2 vs 30.2, P = 0.070). The CTA group had a significantly lower surgery task load index sore than the non-CTA group (36.6 vs 41.7, P < 0.001). There was no significant difference in postoperative complications rate of 14.5% in the CTA group and 22.5% in the non-CTA group (difference, - 8.0% [95% CI, - 16.0 to 0.1]; P = 0.053).
CONCLUSION
Preoperative CTA associated with surgical decision-making could relieve surgery burden and lead to a better surgical performance compared with non-CTA support, which including decreased blood loss volume, vessel damage and operation time.
TRIAL REGISTRATION
NCT04636099.
背景
与开腹手术相比，腹腔镜胃切除术缺乏手部直接触觉，手术视野有限。除了教科书上的分类外，胃动脉还存在解剖变异。腹腔镜胃切除术存在技术难题，与开放手术相比，需要更全面地了解局部解剖结构。我们旨在比较术前计算机断层扫描血管造影（CTA）与腹腔镜胃切除术手术决策的有效性和安全性。
方法
GISSG 20-01研究是一项多中心、开放标签、随机临床试验。纳入标准主要包括组织学确诊的BMI≥25kg/m的胃癌患者。符合条件的患者以1:1的比例随机分配到CTA组或非CTA组。主要终点是术中失血量。
结果
2020年11月至2021年12月，共纳入382例患者并随机分配。排除25例患者后，357例患者被纳入改良意向性治疗人群（CTA组179例，非CTA组178例）。CTA组的平均术中失血量（CTA组与非CTA组；74.2 vs 95.0mL，P = 0.005）和手术时间（215.4 vs 231.2分钟，P = 0.004）显著更低。两组的总淋巴结切除数相似（32.2 vs 30.2，P = 0.070）。CTA组的手术任务负荷指数疼痛明显低于非CTA组（36.6 vs 41.7，P < 0.001）。CTA组术后并发症发生率为14.5%，非CTA组为22.5%，差异无统计学意义（差异，-8.0%[95%CI，-16.0至0.1]；P = 0.053）。
结论
与非CTA支持相比，术前CTA与手术决策相关可减轻手术负担，带来更好的手术表现，包括减少失血量、血管损伤和手术时间。试验注册：NCT04636099。
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