Drain Placement After Uncomplicated Hepatic Resection Increases Severe Postoperative Complication Rate A Japanese Multi-institutional Randomized Controlled Trial (ND-trial)
Drain Placement After Uncomplicated Hepatic Resection Increases Severe Postoperative Complication Rate A Japanese Multi-institutional Randomized Controlled Trial (ND-trial)
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DOI：
10.1097/sla.0000000000004051
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发表时间：
2021-02-01
影响因子：
9
通讯作者：
Shimada, Kazuaki
中科院分区：
文献类型：
--
作者：
Arita, Junichi;Sakamaki, Kentaro;Shimada, Kazuaki
目的：评价肝切除术后不引流的临床效果。背景数据总结：以前的随机对照试验，解决肝切除术后无引流政策似乎是不确定的，因为他们没有采用适当的研究设计，以验证其真正的临床影响。方法：这项非盲随机对照试验在7家日本机构进行。接受肝切除术但未行胆道重建的患者随机分为D组或ND组。当认为术后胆漏或出血的风险较高时，患者在手术过程中被排除在外。主要终点为术后90天内C-D 3级或以上的术后并发症。评估ND组相对于D组的非劣效性，如果证实，则评估优效性。结果如下：2015年5月至2017年7月，最终共有400例患者纳入符合方案集分析：D组199例患者，ND组201例患者。术中，37例患者因胆漏或出血的高风险而从最终入选中排除。D组术后C-D 3级或以上并发症发生率为8.0%（16/199），ND组为2.5%（5/201）。风险差异为-5.5%（95%置信区间：-9.9%至-1.2%），符合规定的非劣效性界值4%。两组均未发生术后死亡。胆漏发生率D组为8.0%（16/199），ND组为0（P < 0.001）。在根据8个潜在相关因素分类的亚组中，没有一个亚组在C-D 3级或更高并发症方面有利于引流放置。结论：单纯肝切除术后不应放置引流管。
Objective: To assess the clinical impact of a no-drain policy after hepatic resection. Summary of Background Data: Previous randomized controlled trials addressing no-drain policy after hepatic resection seem inconclusive because they did not adopt appropriate study design to validate its true clinical impact. Methods: This unblinded, randomized controlled trial was done at 7 Japanese institutions. Patients undergoing hepatic resection without biliary reconstruction were randomized to either D group or ND group. When the risk of postoperative bile leakage or hemorrhage were considered high, the patients were excluded during the operation. Primary endpoint was the postoperative complication of C-D grade 3 or higher within 90 postoperative days. A noninferiority of ND group to D group was assessed, and if it was confirmed, a superiority was assessed. Results: Between May 2015 and July 2017, a total of 400 patients were finally included in the per-protocol set analysis: 199 patients in D group and 201 patients in ND group. Intraoperatively, 37 patients were excluded from the final enrollment because of high risk of bile leakage or hemorrhage. Postoperative complication rate of C-D grade 3 or higher was 8.0% (16/199) in the D group and 2.5% (5/201) in the ND group. The risk difference was -5.5% (95% confidence interval: -9.9% to -1.2%) and fulfilled the prescribed noninferiority margin of 4%. No postoperative mortality was experienced in both groups. Bile leakage was diagnosed in 8.0% (16/199) of the D group and none in the ND group (P < 0.001). In none of the subgroups classified based on 8 potentially relevant factors, drain placement was favored in terms of C-D grade 3 or higher complication. Conclusions: Drains should not be placed after uncomplicated hepatic resections.