Overview

Conditions pancreatic cancer, cancer of the duodenum, cholangiocarcinoma, chronic pancreatitis
Treatments enteral nutrition, oral nutrition
Phase phase 4
Sponsor Medical University of Warsaw
Start date November 2016
End date December 2019
Trial size 96 participants
Trial identifier NCT01642875, PerOsEnteral1

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.

Recruiting in the following locations…

United States No locations recruiting
Other Countries Poland

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
early enteral nutrition with standard enteral formulas administered through a nasojejunal tube
enteral nutrition standard enteral formula
Standard enteral diet is administered through a nasojejunal tube. Enteral nutrition is started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level.
(Active Comparator)
early oral nutrition with hospital diets and oral formulas
oral nutrition oral diet
Oral diet is started from the 2nd postoperative day and oral intake is advanced as tolerated

Primary Outcomes

Measure
Frequency of delayed gastric emptying
time frame: 30 days after operation

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Primary periampullary tumor - R0, R1 resection - Chronic pancreatitis requiring pancreatoduodenectomy Exclusion Criteria: - Metastatic tumor - Locally unresectable tumor - Previous gastric resection - ASA IV-V - Age under 18 years - Preoperative complete parenteral or enteral feeding - Immunosuppressive therapy before operation - Severe malnutrition - Lack of the patient's consent for the trial participation, feeding tube insertion or epidural analgesia

Additional Information

Official title Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy for Periampullary Tumors: a Prospective, Randomized, Controlled Clinical Trial
Principal investigator Marek Wronski, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Medical University of Warsaw.