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Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01642875
Enrollment
96
Registered
2012-07-17
Start date
2016-11-30
Completion date
2020-12-31
Last updated
2016-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of the Duodenum, Cholangiocarcinoma, Chronic Pancreatitis, Pancreatic Cancer

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

OTHEREnteral nutrition

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.

OTHEROral nutrition

Oral diet is started from the 2nd postoperative day and oral intake is advanced as tolerated

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frame
Frequency of delayed gastric emptying30 days after operation

Secondary

MeasureTime frame
Perioperative mortality rate60 days after operation
Postoperative hospital stay length60 days after operation
Overall morbidity rate60 days after operation
Time to resolution of paralytic ileus7 days after operation
Rehospitalization rate30 days after discharge
Time to full oral nutrition60 days after operation

Countries

Poland

Contacts

Primary ContactMaciej Słodkowski, MD
maciejslodkowski@wp.pl0048 22 599 2251
Backup ContactMarek Wroński, MD
mwronski@vp.pl0048 22 599 2482

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026