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Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy

NCT ID: NCT01642875

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Pancreatic Cancer Cancer of the Duodenum Cholangiocarcinoma Chronic Pancreatitis

Keywords

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Periampullary tumor Chronic pancreatitis Pancreatoduodenectomy Oral Nutrition Enteral Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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EN

early enteral nutrition with standard enteral formulas administered through a nasojejunal tube

Group Type EXPERIMENTAL

Enteral nutrition

Intervention Type OTHER

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.

PerOs

early oral nutrition with hospital diets and oral formulas

Group Type ACTIVE_COMPARATOR

Oral nutrition

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Oral nutrition

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

Intervention Type OTHER

Other Intervention Names

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standard enteral formula oral diet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maciej Słodkowski, MD

Role: STUDY_DIRECTOR

Medical University of Warsaw

Marek Wronski, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

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Sp Csk Wum

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Maciej Słodkowski, MD

Role: CONTACT

Phone: 0048 22 599 2251

Email: [email protected]

Marek Wroński, MD

Role: CONTACT

Phone: 0048 22 599 2482

Email: [email protected]

Facility Contacts

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Marek Wroński, MD,PhD

Role: primary

Marcin Makiewicz, MD

Role: backup

Other Identifiers

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PerOsEnteral1

Identifier Type: -

Identifier Source: org_study_id