Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy

November 22, 2016 updated by: Medical University of Warsaw

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EN
early enteral nutrition with standard enteral formulas administered through a nasojejunal tube
Other: Enteral 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.
Other Names:
  • standard enteral formula
ACTIVE_COMPARATOR: PerOs
early oral nutrition with hospital diets and oral formulas
Other: Oral nutrition
Oral diet is started from the 2nd postoperative day and oral intake is advanced as tolerated
Other Names:
  • oral diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of delayed gastric emptying
Time Frame: 30 days after operation
30 days after operation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Study Director: Maciej Słodkowski, MD, Medical University of Warsaw
  • Principal Investigator: Marek Wronski, MD, Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

July 9, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (ESTIMATE)

July 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PerOsEnteral1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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