Efficacy and safety of subserosal versus submucosal carbon nanoparticle-guided laparoscopic radical gastrectomy (DANCE-04): A randomized clinical trial.
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引用次数: 0
Abstract
Background: To compare the efficacy in lymph node dissection, perioperative safety, and cost of subserosal and submucosal administration of carbon nanoparticles in laparoscopic radical gastrectomy for gastric cancer.
Methods: This was a randomized clinical trial. Patients with potentially resectable gastric cancer (cT1-4a, cNany, cM0) were randomized into subserosal or submucosal groups. Laparoscopic D2 lymphadenectomy was performed for each patient.
Results: Between September 2023 and August 2024, 49 patients were enrolled in the subserosal group and 50 patients were enrolled in the submucosal group. The number of retrieved lymph nodes in the subserosal group was significantly greater than that in the submucosal group (36.6 ± 1.4 vs 32.2 ± 1.4, P = .02). The number of retrieved metastatic lymph nodes in the subserosal group was also significantly greater than that in the submucosal group (3.1 ± 0.6 vs 1.5 ± 0.5, P = .04). The duration of surgery in the subserosal group was shorter than that in the submucosal group (150.9 ± 3.0 minutes vs 194.7 ± 6.2 minutes, P < .001). The tracing-related cost in the subserosal group was lower than that in the submucosal group (1,824.8 ± 110.9 vs 2,395.5 ± 112.5 [in Chinese currency], P < .001), whereas the tracing-excluded cost was similar between groups. Diagnostic values, including sensitivity, specificity, positive predictive value, and negative predictive value for metastatic stations or lymph nodes, of the subserosal approach were superior to those of the submucosal approach.
Conclusion: Subserosal is superior to submucosal administration of carbon nanoparticles in lymph node dissection with comparable perioperative safety and decreased tracing-related cost in laparoscopic radical gastrectomy for gastric cancer.
背景：比较腹腔镜胃癌根治术中膜下和粘膜下给药纳米碳在淋巴结清扫方面的疗效、围手术期安全性和成本。方法：随机临床试验。可切除的胃癌患者（cT1-4a, cNany, cM0）随机分为浆膜下组或粘膜下组。每例患者均行腹腔镜D2淋巴结切除术。结果：2023年9月至2024年8月，49例患者入组于浆膜下组，50例患者入组于粘膜下组。浆膜下组淋巴结清扫数明显多于粘膜下组（36.6±1.4 vs 32.2±1.4,P = 0.02）。浆膜下组的淋巴结清扫数明显多于粘膜下组（3.1±0.6 vs 1.5±0.5,P = 0.04）。膜下组手术时间短于粘膜下组（150.9±3.0 min vs 194.7±6.2 min, P < 0.001）。粘膜下组的追踪相关成本低于粘膜下组（1,824.8±110.9 vs 2,395.5±112.5[中国货币]，P < 0.001），而两组之间的追踪排除成本相似。浆膜下入路的诊断价值，包括对转移灶或淋巴结的敏感性、特异性、阳性预测值和阴性预测值均优于粘膜下入路。结论：在腹腔镜胃癌根治术中，膜下给药优于粘膜下给药，其围手术期安全性相当，并降低了追踪相关费用。试验注册：ISRCTN11247387 （https://doi.org/10.1186/ISRCTN11247387）。
期刊介绍：
For 66 years, Surgery has published practical, authoritative information about procedures, clinical advances, and major trends shaping general surgery. Each issue features original scientific contributions and clinical reports. Peer-reviewed articles cover topics in oncology, trauma, gastrointestinal, vascular, and transplantation surgery. The journal also publishes papers from the meetings of its sponsoring societies, the Society of University Surgeons, the Central Surgical Association, and the American Association of Endocrine Surgeons.
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