Clinical Trial: Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy for Periampullary Tumors: a Prospective, Randomized, Controlled Clinical Trial

Brief Summary:

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.

The purpose of this study is to compare the influence of early enteral and oral nutrition on postoperative course and complications after pancreatoduodenectomy.

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. 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.


Detailed Summary:

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
Sponsor: Medical University of Warsaw

Current Primary Outcome: Frequency of delayed gastric emptying [ Time Frame: 30 days after operation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall morbidity rate [ Time Frame: 60 days after operation ]
  • Perioperative mortality rate [ Time Frame: 60 days after operation ]
  • Postoperative hospital stay length [ Time Frame: 60 days after operation ]
  • Time to full oral nutrition [ Time Frame: 60 days after operation ]
  • Time to resolution of paralytic ileus [ Time Frame: 7 days after operation ]
  • Rehospitalization rate [ Time Frame: 30 days after discharge ]


Original Secondary Outcome: Same as current

Information By: Medical University of Warsaw

Dates:
Date Received: July 9, 2012
Date Started: November 2016
Date Completion: December 2020
Last Updated: November 22, 2016
Last Verified: November 2016