Department of Surgical Oncology, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.
Fellowship of Oncosurgery, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.
BMC Surg. 2021 Mar 21;21(1):155. doi: 10.1186/s12893-021-01168-5.
Disturbance in the lymphatic drainage during D2 dissection is associated with significant morbidity. We aimed to assess the effect of fibrin glue on the reduction of postoperative lymphatic leakage.
Prospective double-blinded randomized clinical trial with forty patients in each study arm was conducted. All patients diagnosed, staged, and became a candidate for D2 dissection based on NCCN 2019 guideline for gastric cancer. The intervention group received 1 cc of IFABOND® applied to the surgical bed.
The difference between study groups regarding age, gender, tumor stage was insignificant. (All p-values > 0.05). The median daily drainage volume was 120 ml with the first and the third interquartile being 75 and 210 ml, respectively for the intervention group. The control group had median, the first, and the third interquartile of 350, 290, and 420 ml. The difference between daily drainage volumes was statistically significant (p-value < 0.001). The length of hospital stay was significantly different between the two groups. Notably, the intervention group was discharged sooner (median of 7 Vs 9 days, p-value: 0.001).
This study showed the possible role of fibrin glue in reducing postoperative lymphatic leakage after gastrectomy and D2 dissection. Registration trial number: IRCT20200710048071N1, 2020.08.16.
D2 清扫术中淋巴管引流的干扰与显著的发病率有关。我们旨在评估纤维蛋白胶对减少术后淋巴漏的影响。
对 40 例患者进行前瞻性双盲随机临床试验，每组 20 例。所有患者均根据 NCCN 2019 年胃癌指南进行诊断、分期并成为 D2 清扫术的候选者。干预组接受 1cc 的 IFABOND®施用于手术床。
研究组间在年龄、性别、肿瘤分期方面的差异无统计学意义（所有 p 值均>0.05）。干预组的每日引流量中位数为 120ml，第一和第三四分位数分别为 75 和 210ml。对照组的中位数、第一和第三四分位数分别为 350、290 和 420ml。每日引流量的差异具有统计学意义（p 值<0.001）。两组间的住院时间存在显著差异。值得注意的是，干预组的出院时间更早（中位数为 7 天对 9 天，p 值：0.001）。
本研究表明纤维蛋白胶在减少胃癌和 D2 清扫术后术后淋巴漏方面可能发挥作用。注册号：IRCT20200710048071N1，2020.08.16.
