Liu Xinchun, Chen Qiuyang, Fu Yue, Lu Zipeng, Chen Jianmin, Guo Feng, Li Qiang, Wu Junli, Gao Wentao, Jiang Kuirong, Dai Cuncai, Miao Yi, Wei Jishu
Pancreas Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Department of General Surgery, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Front Oncol. 2021 Apr 29;11:656332. doi: 10.3389/fonc.2021.656332. eCollection 2021.
The aim of this study was to test the hypothesis that early oral feeding (EOF) is superior to early nasojejunal nutrition (ENN) after pylorus-preserving pancreaticoduodenectomy (PPPD) in terms of delayed gastric emptying (DGE).
DGE is a common complication after PPPD. Although EOF after PPPD is recommended by several international guidelines, there is no randomized trial to support this recommendation.
From September 2016 to December 2017, a total of 120 patients undergoing PPPD were randomized into the ENN, EOF, or saline groups at a 1:1:1 ratio (40 patients in each group). The primary endpoint was the rate of clinically relevant DGE. Secondary endpoints included overall morbidity, postoperative pancreatic fistula, post-pancreatectomy hemorrhage, abdominal infection, length of hospital stay, reoperation rate, and in-hospital mortality.
The baseline characteristics and operative parameters were comparable between the groups. The incidence of clinically relevant DGE varied significantly among the three groups (ENN, 17.5%; EOF, 10.0%; saline, 32.5%; p =0.038). The saline group had a higher clinically relevant DGE rate than the EOF group (p = 0.014). The saline group also had greater overall morbidities than the ENN and EOF groups (p = 0.041 and p = 0.006, respectively). There were no significant differences in other surgical complication rates or postoperative hospital stay. No mortality was observed in any of the groups.
Nutritional support methods were not related to DGE after PPPD. EOF was feasible and safe after PPPD, and additional ENN should not be routinely administered to patients after PPPD.
ClinicalTrials.gov, identifier NCT03150615.
本研究旨在验证以下假设：在保留幽门的胰十二指肠切除术（PPPD）后，就胃排空延迟（DGE）而言，早期经口喂养（EOF）优于早期经鼻空肠营养（ENN）。
DGE是PPPD术后的常见并发症。尽管多项国际指南推荐PPPD术后采用EOF，但尚无随机试验支持这一推荐。
2016年9月至2017年12月，共有120例行PPPD的患者按1:1:1的比例随机分为ENN组、EOF组或生理盐水组（每组40例）。主要终点是临床相关DGE的发生率。次要终点包括总体发病率、术后胰瘘、胰十二指肠切除术后出血、腹腔感染、住院时间、再次手术率和住院死亡率。
各组间基线特征和手术参数具有可比性。三组临床相关DGE的发生率差异显著（ENN组为17.5%；EOF组为10.0%；生理盐水组为32.5%；p = 0.038）。生理盐水组临床相关DGE发生率高于EOF组（p = 0.014）。生理盐水组总体发病率也高于ENN组和EOF组（分别为p = 0.041和p = 0.006）。其他手术并发症发生率或术后住院时间无显著差异。各组均未观察到死亡病例。
PPPD术后营养支持方式与DGE无关。PPPD术后EOF可行且安全，PPPD术后患者不应常规给予额外的ENN。
ClinicalTrials.gov，标识符NCT03150615。
