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Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01642875
First received: July 9, 2012
Last updated: July 16, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Cancer of the Duodenum
Cholangiocarcinoma
Chronic Pancreatitis
 Other: Enteral nutrition
Other: Oral nutrition
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy for Periampullary Tumors: a Prospective, Randomized, Controlled Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • Frequency of delayed gastric emptying [ Time Frame: 30 days after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall morbidity rate [ Time Frame: 60 days after operation ] [ Designated as safety issue: No ]
  • Perioperative mortality rate [ Time Frame: 60 days after operation ] [ Designated as safety issue: No ]
  • Postoperative hospital stay length [ Time Frame: 60 days after operation ] [ Designated as safety issue: No ]
  • Time to full oral nutrition [ Time Frame: 60 days after operation ] [ Designated as safety issue: No ]
  • Time to resolution of paralytic ileus [ Time Frame: 7 days after operation ] [ Designated as safety issue: No ]
  • Rehospitalization rate [ Time Frame: 30 days after discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: July 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: oral diet

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642875

Locations
Poland
Sp Csk Wum
Warsaw, Poland, 02-097
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Study Director: Maciej Słodkowski, MD Medical University of Warsaw
Principal Investigator: Marek Wronski, MD Medical University of Warsaw
  More Information

No publications provided

Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01642875     History of Changes
Other Study ID Numbers: PerOsEnteral1
Study First Received: July 9, 2012
Last Updated: July 16, 2012
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Warsaw:
Periampullary tumor
Chronic pancreatitis
Pancreatoduodenectomy
Oral Nutrition
Enteral Nutrition

Additional relevant MeSH terms:
Duodenal Neoplasms
Pancreatic Neoplasms
Pancreatitis
Pancreatitis, Chronic
Cholangiocarcinoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 23, 2013