Cancer of the Duodenum, Cholangiocarcinoma, Chronic Pancreatitis, Pancreatic Cancer
Conditions
Keywords
Periampullary tumor, Chronic pancreatitis, Pancreatoduodenectomy, Oral Nutrition, Enteral Nutrition
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 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.
Interventions
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.
Oral diet is started from the 2nd postoperative day and oral intake is advanced as tolerated
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of delayed gastric emptying | 30 days after operation |
Secondary
| Measure | Time frame |
|---|---|
| Perioperative mortality rate | 60 days after operation |
| Postoperative hospital stay length | 60 days after operation |
| Overall morbidity rate | 60 days after operation |
| Time to resolution of paralytic ileus | 7 days after operation |
| Rehospitalization rate | 30 days after discharge |
| Time to full oral nutrition | 60 days after operation |
Countries
Poland