Randomized trial of oral versus enteral feeding for patients with postoperative pancreatic fistula after pancreatoduodenectomy
Journal
British Journal of Surgery
Journal Volume
106
Journal Issue
3
Pages
190-198
Date Issued
2019
Author(s)
Chen H.-A.
Lai S.-R.
Hsu S.-Y.
Ho T.-W.
Abstract
Background: 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. Methods: 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. Results: 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. Conclusion: 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). ? 2019 BJS Society Ltd Published by John Wiley & Sons Ltd
SDGs
Other Subjects
amylase; cholecystokinin; abdominal abscess; adult; Article; computer assisted tomography; controlled study; enteric feeding; female; follow up; gastrojejunostomy; hospital cost; hospitalization; human; length of stay; major clinical study; male; middle aged; multicenter study; oral feeding; pancreas fistula; pancreas secretion; pancreaticoduodenectomy; pancreaticojejunostomy; parenteral nutrition; postoperative complication; priority journal; randomized controlled trial; recurrent disease; stomach paresis; clinical trial; comparative study; eating; pancreas fistula; pancreaticoduodenectomy; postoperative care; postoperative complication; procedures; statistics and numerical data; treatment outcome; Eating; Enteral Nutrition; Female; Humans; Length of Stay; Male; Middle Aged; Pancreatic Fistula; Pancreaticoduodenectomy; Postoperative Care; Postoperative Complications; Treatment Outcome
Publisher
John Wiley and Sons Ltd
Type
journal article