Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea.
Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
J Hepatobiliary Pancreat Sci. 2019 Aug;26(8):360-369. doi: 10.1002/jhbp.641. Epub 2019 Jul 2.
This study aims to investigate the noninferiority of Enhanced Recovery After Surgery (ERAS) for pancreaticoduodenectomy (PD).
In this single-center trial, we randomly assigned 276 adult patients who underwent open PD into ERAS and conventional groups with 138 patients in each, from 2015 through 2017. The primary endpoint was the incidence of overall morbidity until postoperative 3 months. The secondary endpoints were in-hospital or 30-day mortality, postoperative length of stay (LOS), nutritional status and overall hospital costs.
Overall morbidity was reported in 64 patients (52.0%, ERAS group) and in 68 patients (54.8%, conventional group) (risk difference [RD] -2.81 percentage points (pp); 90% two-sided confidence interval -13.24 to 7.63). Mortality did not occur in any patients. The two groups did not differ significantly in median postoperative LOS (both 11 days; RD -8.46 pp), body mass index (22.4 ± 2.75 vs. 22.4 ± 2.65 kg/m ; RD -3.48 pp), Patient-Generated Subjective Global Assessment score over 4 (45 [40.5%] vs. 50 [43.1%] patients; RD -2.56 pp), and median overall hospital cost (15.61 vs. 16.04, ×10 KRW; RD -6.08 pp).
Even in PD, modified ERAS protocol was not inferior to conventional protocol, while reducing treatment burden.
本研究旨在探究胰十二指肠切除术（PD）中加速康复外科（ERAS）方案的非劣效性。
在这项单中心试验中，我们将 2015 年至 2017 年间接受开腹 PD 的 276 例成年患者随机分配至 ERAS 组和常规组，每组 138 例。主要终点是术后 3 个月内总体发病率。次要终点包括院内或 30 天死亡率、术后住院时间（LOS）、营养状况和总住院费用。
共有 64 例（52.0%，ERAS 组）和 68 例（54.8%，常规组）患者出现总体发病率（风险差异 [RD] -2.81 个百分点 [90%双侧置信区间 -13.24 至 7.63]）。两组均无患者死亡。两组术后 LOS 中位数无显著差异（均为 11 天；RD -8.46 个百分点）、BMI（22.4 ± 2.75 vs. 22.4 ± 2.65 kg/m2；RD -3.48 个百分点）、PG-SGA 评分≥4 分（45 [40.5%] 例 vs. 50 [43.1%] 例；RD -2.56 个百分点）和 LOS 中位数（15.61 比 16.04 韩元×10 万韩元；RD -6.08 个百分点）。
即使在 PD 中，改良 ERAS 方案也不劣于常规方案，同时减轻了治疗负担。
