加速康复外科方案下胰十二指肠切除术后肠内营养与肠外营养的比较：一项多中心、开放标签随机对照试验的研究方案（ENE-PAN 试验）。
Enteral versus parental nutrition after pancreaticoduodenectomy under enhanced recovery after surgery protocol: study protocol for a multicenter, open-label randomized controlled trial (ENE-PAN trial).
机构信息
Department of Hepatobiliary-Pancreatic Surgery, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan.
Department of Surgery, National Defense Medical College, Tokorozawa, Saitama, Japan.
出版信息
Trials. 2022 Oct 29;23(1):917. doi: 10.1186/s13063-022-06856-y.
BACKGROUND
Infectious complications are the main causes of morbidity after pancreaticoduodenectomy (PD). Early enteral nutrition (EN) is a reasonable form of nutritional support that aims to mitigate the occurrence and severity of infectious complications by maintaining gut immunity. However, it remains unclear whether EN is beneficial for patients who underwent PD and are under enhanced recovery after surgery (ERAS) protocol.
METHODS
A multicenter (six hospitals), open-label, randomized controlled trial will be started in July 2022. A total of 320 patients undergoing open PD will be randomly assigned to an EN group or a peripheral parental nutrition (PPN) group in a 1:1 ratio. The stratification factors will be the hospital, age (≥ 70 or not), and preoperative diagnosis (pancreatic cancer or not). In the EN group, enteral nutrition will start on postoperative day (POD) 1 at 200-300 ml/day via the percutaneous tube placed operatively. The volume of the diet will be increased to 400-600 ml/day on POD 2 and depend on the surgeon's decision from POD 3. In the PPN group, PPN will be delivered after surgery. In both groups, oral feeding will start on POD 3. Each treatment will be finished when patients' oral food intake reaches 60% of the nutritional requirement (25-30 kcal/day). The primary endpoint will be the occurrence of postoperative infectious complications within 90 days of surgery. The secondary endpoints will be all complications, including major ones such as Clavien-Dindo grade 3 or more and clinically relevant postoperative pancreatic fistula. Data will be analyzed per the intention to treat.
DISCUSSION
This will be the first, large, and well-designed RCT that aims to determine whether EN is beneficial for patients who underwent PD under the ERAS protocol. According to the results of this study, either EN or PPN would be adopted as the standard nutritional support for patients undergoing PD.
TRIAL REGISTRATION
jRCT1030210691. Registered on March 23, 2022.
背景
感染并发症是胰十二指肠切除术（PD）后发病率的主要原因。早期肠内营养（EN）是一种合理的营养支持形式，旨在通过维持肠道免疫来减轻感染并发症的发生和严重程度。然而，对于接受 PD 并接受术后强化康复（ERAS）方案的患者，EN 是否有益仍不清楚。
方法
一项多中心（六家医院）、开放标签、随机对照试验将于 2022 年 7 月开始。共有 320 名接受开腹 PD 的患者将按照 1:1 的比例随机分配到 EN 组或外周肠外营养（PPN）组。分层因素将是医院、年龄（≥70 岁或否）和术前诊断（胰腺癌或否）。在 EN 组中，术后第 1 天（POD）1 经手术放置的经皮管以 200-300ml/天开始进行肠内营养。在 POD2 时，饮食量将增加到 400-600ml/天，并且从 POD3 开始取决于外科医生的决定。在 PPN 组中，手术后将进行 PPN。在两组中，POD3 开始口服喂养。当患者的口服食物摄入量达到营养需求的 60%（25-30kcal/天）时，每个治疗都将结束。主要终点是术后 90 天内发生的术后感染并发症。次要终点是所有并发症，包括 Clavien-Dindo 分级 3 级或更高级别的主要并发症和临床上相关的术后胰瘘。数据将按照意向治疗进行分析。
讨论
这将是第一项旨在确定 EN 是否有益于接受 ERAS 方案的 PD 患者的大型、精心设计的 RCT。根据这项研究的结果，EN 或 PPN 将被采用为接受 PD 的患者的标准营养支持。
试验注册
jRCT1030210691。于 2022 年 3 月 23 日注册。
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