Short-term outcomes of preoperative computed tomography angiography versus standard assessment in patients with BMI ≥ 25.0 kg/m2 undergoing laparoscopic gastrectomy: the GISSG20-01 randomized clinical trial.
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引用次数: 0
Abstract
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/m2. 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.
背景:与剖腹手术相比,腹腔镜胃切除术缺乏手直接触觉,手术范围有限。除了教科书上的分类,胃动脉也有解剖学上的差异。腹腔镜胃切除术存在技术上的困难,需要比开放手术更全面地理解区域解剖。我们的目的是比较术前计算机断层血管造影(CTA)与腹腔镜胃切除术手术决策相关的有效性和安全性。方法:GISSG 20-01研究是一项多中心、开放标签、随机临床试验。入选标准主要为组织学证实的BMI≥25 kg/m2的胃癌患者。符合条件的患者按1:1的比例随机分为CTA组和非CTA组。主要终点是术中出血量。结果:在2020年11月至2021年12月期间,382名患者入组并随机分配。在排除25例患者后,357例患者被纳入改良意向治疗人群(179例CTA组,178例非CTA组)。平均术中出血量(CTA vs非CTA;CTA组74.2 vs 95.0 mL, P = 0.005),手术时间(215.4 vs 231.2 min, P = 0.004)显著缩短。两组淋巴结清扫总数相似(32.2 vs 30.2, P = 0.070)。CTA组的手术任务负荷指数明显低于非CTA组(36.6 vs 41.7), P结论:术前CTA辅助手术决策可减轻手术负担,手术效果优于非CTA组,包括出血量减少、血管损伤减少、手术时间缩短等。试验注册:NCT04636099。
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