Department of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
Department of Surgery, Shuang Ho Hospital, Taipei Medical University College of Medicine, Taipei, Taiwan.
Br J Surg. 2019 Feb;106(3):190-198. doi: 10.1002/bjs.11087.
Whether continued oral feeding may have a negative impact on healing of postoperative pancreatic fistula (POPF) is unclear. The aim was to test the hypothesis that oral feeding is non-inferior to enteral feeding in closure of POPF after pancreatoduodenectomy, and to clarify the effects of oral feeding on the duration and grade of POPF.
This multicentre, non-inferiority randomized trial of oral or enteral feeding of patients with POPF after pancreatoduodenectomy recruited patients between August 2013 and September 2016. The primary efficacy outcome was the 30-day fistula closure rate. The prespecified non-inferiority margin was 15 per cent. Other efficacy outcomes included grade of fistula, and hospital stay and costs.
A total of 114 patients were included, and received oral (57) or enteral (57) feeding. The two groups were balanced in baseline characteristics and no patient was lost to follow-up. In intention-to-treat analysis, oral feeding was non-inferior to enteral feeding in terms of 30-day fistula closure rate (88 versus 89 per cent respectively; difference -1·8 per cent, lower limit of 95 per cent c.i. -14·4 per cent; P = 0·020 for non-inferiority). Compared with enteral feeding, oral feeding significantly reduced hospital costs and duration of stay. No significant differences were noted in the number of patients whose POPF evolved into grade B/C, or other outcomes.
Oral feeding in patients with POPF after pancreatoduodenectomy did not increase the duration or grade of POPF, and was associated with reduced duration of stay and hospital costs. Registration number: NCT01755260 (http://www.clinicaltrials.gov).
术后胰瘘（POPF）患者继续口服喂养是否会产生负面影响尚不清楚。本研究旨在检验口服喂养在胰十二指肠切除术后闭合 POPF 方面不劣于肠内喂养的假设，并阐明口服喂养对 POPF 持续时间和严重程度的影响。
本多中心、非劣效性随机试验纳入了胰十二指肠切除术后发生 POPF 的患者，比较了口服或肠内喂养的效果。该试验于 2013 年 8 月至 2016 年 9 月期间招募患者。主要疗效终点为 30 天瘘闭合率。预设的非劣效性边界为 15%。其他疗效终点包括瘘的严重程度、住院时间和费用。
共纳入 114 例患者，分别接受口服（57 例）或肠内（57 例）喂养。两组在基线特征方面平衡，无失访患者。意向治疗分析显示，在 30 天瘘闭合率方面，口服喂养与肠内喂养无差异（分别为 88%和 89%；差异-1.8%，95%置信区间下限-14.4%；P=0.020 用于非劣效性）。与肠内喂养相比，口服喂养显著降低了住院费用和住院时间。两组患者中 POPF 进展为 B/C 级或其他结局的患者数量无显著差异。
胰十二指肠切除术后 POPF 患者口服喂养不会增加 POPF 的持续时间或严重程度，且与缩短住院时间和降低住院费用有关。注册号：NCT01755260（http://www.clinicaltrials.gov）。
