Clinical trial NCT01642875: Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy
Official title: Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy for Periampullary Tumors: a Prospective, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pancreatic Cancer
Cancer of the Duodenum
Cholangiocarcinoma
Chronic Pancreatitis
Keywords: Periampullary tumor
Chronic pancreatitis
Pancreatoduodenectomy
Oral Nutrition
Enteral Nutrition
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of delayed gastric emptying
timeFrame: 30 days after operation
Secondary outcomes:
measure: Overall morbidity rate
timeFrame: 60 days after operation
measure: Perioperative mortality rate
timeFrame: 60 days after operation
measure: Postoperative hospital stay length
timeFrame: 60 days after operation
measure: Time to full oral nutrition
timeFrame: 60 days after operation
measure: Time to resolution of paralytic ileus
timeFrame: 7 days after operation
measure: Rehospitalization rate
timeFrame: 30 days after discharge
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Sp Csk Wum
Study officials:
affiliation: Medical University of Warsaw
name: Maciej Słodkowski, MD
role: STUDY_DIRECTOR
affiliation: Medical University of Warsaw
name: Marek Wronski, MD
role: PRINCIPAL_INVESTIGATOR
References: