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Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy

Primary Purpose

Pancreatic Cancer, Cancer of the Duodenum, Cholangiocarcinoma

Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Enteral nutrition
Oral nutrition
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatic Cancer focused on measuring Periampullary tumor, Chronic pancreatitis, Pancreatoduodenectomy, Oral Nutrition, Enteral Nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sp Csk WumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EN

PerOs

Arm Description

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

early oral nutrition with hospital diets and oral formulas

Outcomes

Primary Outcome Measures

Frequency of delayed gastric emptying

Secondary Outcome Measures

Overall morbidity rate
Perioperative mortality rate
Postoperative hospital stay length
Time to full oral nutrition
Time to resolution of paralytic ileus
Rehospitalization rate

Full Information

First Posted
July 9, 2012
Last Updated
November 22, 2016
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT01642875
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Cancer of the Duodenum, Cholangiocarcinoma, Chronic Pancreatitis
Keywords
Periampullary tumor, Chronic pancreatitis, Pancreatoduodenectomy, Oral Nutrition, Enteral Nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EN
Arm Type
Experimental
Arm Description
early enteral nutrition with standard enteral formulas administered through a nasojejunal tube
Arm Title
PerOs
Arm Type
Active Comparator
Arm Description
early oral nutrition with hospital diets and oral formulas
Intervention Type
Other
Intervention Name(s)
Enteral nutrition
Other Intervention Name(s)
standard enteral formula
Intervention Description
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
Intervention Name(s)
Oral nutrition
Other Intervention Name(s)
oral diet
Intervention Description
Oral diet is started from the 2nd postoperative day and oral intake is advanced as tolerated
Primary Outcome Measure Information:
Title
Frequency of delayed gastric emptying
Time Frame
30 days after operation
Secondary Outcome Measure Information:
Title
Overall morbidity rate
Time Frame
60 days after operation
Title
Perioperative mortality rate
Time Frame
60 days after operation
Title
Postoperative hospital stay length
Time Frame
60 days after operation
Title
Time to full oral nutrition
Time Frame
60 days after operation
Title
Time to resolution of paralytic ileus
Time Frame
7 days after operation
Title
Rehospitalization rate
Time Frame
30 days after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maciej Słodkowski, MD
Phone
0048 22 599 2251
Email
maciejslodkowski@wp.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Marek Wroński, MD
Phone
0048 22 599 2482
Email
mwronski@vp.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maciej Słodkowski, MD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marek Wronski, MD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sp Csk Wum
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Wroński, MD,PhD
Phone
+48225992482
Email
mwronski@vp.pl
First Name & Middle Initial & Last Name & Degree
Marcin Makiewicz, MD
Phone
+48225992252
Email
marcin.makiewicz@gmail.com

12. IPD Sharing Statement

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Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy

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