Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy for Periampullary Tumors: a Prospective, Randomized, Controlled Clinical Trial
Background & aim: Pancreatoduodenectomy carries high morbidity rates even in high-volume
centers. Postoperative complications often preclude or delay adequate oral nutrition and
nutritional support may be required. However, the role of perioperative nutritional
supplementation in well-nourished patients remains controversial. There are not any standard
protocols for nutritional support after major upper gastrointestinal surgery in these
patients and postoperative nutritional regimens depend mainly upon surgeon's or center
preference.
Patients undergoing pancreatoduodenectomy often begin oral intake a week after operation and
enteral or parenteral nutrition is used to cover the daily caloric requirements during this
period, although their role still remains questionable. The safety of early oral nutrition
has been confirmed in the majority of gastrointestinal procedures. However, pancreatic
surgeons are quite reluctant to advance oral diet within the first postoperative week after
pancreatoduodenectomy due to fear of anastomosis breakdown or delayed gastric emptying
syndrome. These two postoperative nutritional regimens, early oral vs. early enteral
nutrition, have not been sufficiently evaluated in a prospective, randomized study.
Material and Methods: 96 patients undergoing pancreatoduodenectomy will be randomized to
receive early enteral nutrition (EN group) or early oral nutrition (PerOs group). The EN
group will receive standard enteral diet administered through a nasojejunal tube. The
enteral nutrition will be started on the 1st postoperative day and increased daily by 20-40
ml up to the estimated level. The PerOs group will receive oral diets beginning from the 2nd
postoperative day and oral intake will be advanced as tolerated.
Purpose: The purpose of this study is to compare the influence of early enteral and oral
nutrition on postoperative course and complications after pancreatoduodenectomy.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Frequency of delayed gastric emptying
30 days after operation
No
Maciej SÅ‚odkowski, MD
Study Director
Medical University of Warsaw
Poland: Ethics Committee
PerOsEnteral1
NCT01642875
July 2012
December 2016
Name | Location |
---|