Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy

Phase 4

• Conditions: Pancreatic Cancer; Chronic Pancreatitis; Cancer of the Duodenum; Cholangiocarcinoma
• Interventions: Other: Oral nutrition; Other: Enteral nutrition

• Registration Number: NCT01642875
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-17
• Status Verified: 2016-11
• Study Start: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PerOs	Oral nutrition	early oral nutrition with hospital diets and oral formulas
EN	Enteral nutrition	early enteral nutrition with standard enteral formulas administered through a nasojejunal tube

Primary Outcome Measures

Name	Time	Method
Frequency of delayed gastric emptying	30 days after operation

Secondary Outcome Measures

Name	Time	Method
Overall morbidity rate	60 days after operation
Postoperative hospital stay length	60 days after operation
Time to full oral nutrition	60 days after operation
Time to resolution of paralytic ileus	7 days after operation
Perioperative mortality rate	60 days after operation
Rehospitalization rate	30 days after discharge

Trial Locations

Locations (1)

Sp Csk Wum; 🇵🇱 Warsaw, Poland