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Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy


2007-07


2009-06


2010-01


38

Study Overview

Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. Clinical study on postoperative feeding after pancreaticoduodenectomy is very limited. Method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial. 1. To evaluate whether early enteral nutrition may be a suitable alternative to total parenteral nutrition 2. To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy

Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. The use of TPN significantly increases postoperative complications, especially those associate with infections. However, method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial. 1. To evaluate whether early enteral nutrition may be decreased the postoperative complications 2. To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy 3. To determine the optimal method for postoperative nutritional support

  • Pancreas Cancer
  • Bile Duct Cancer
  • Ampulla of Vater Cancer
  • PROCEDURE: Enteral Feeding and Total Parental Support
  • EN Vs PN

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 Registration Dates Results Reporting Dates Study Record Updates

2008-12-15  

N/A  

2008-12-15  

2008-12-15  

N/A  

2008-12-16  

2008-12-16  

N/A  

2008-12  

Study Plan

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

Design Details

Primary Purpose:
Treatment


Allocation:
Randomized


Interventional Model:
Parallel


Masking:
Double


Arms and Interventions

Participant Group/ArmIntervention/Treatment
OTHER: 1

1. Enteral Feeding

PROCEDURE: Enteral Feeding and Total Parental Support

  • Enteral Feeding : 20ml/hr on POD1 * Velocity is progressively increased by 20ml/d until full nutritional goal (25Kcal/Kg)
NO_INTERVENTION: 2

Total Parental support

PROCEDURE: Enteral Feeding and Total Parental Support

  • Enteral Feeding : 20ml/hr on POD1 * Velocity is progressively increased by 20ml/d until full nutritional goal (25Kcal/Kg)
Primary Outcome MeasuresMeasure DescriptionTime Frame
To evaluate the impact of early postoperative enteral feedingPostoperative 21 days
Secondary Outcome MeasuresMeasure DescriptionTime Frame
To evaluate the nutritional statusPostoperative 6 months

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • Periampullar carcinoma
  • Pancreaticoduonectomy
  • KARNOFSKY PERFORMANCE SCALE > 70
  • No history of Major operation

  • Exclusion Criteria:

  • Creatinine level>3mg/L
  • Ascitis/portal hypertension
  • New York Heart Association class>3
  • COPD
  • Preoperative Radiotheraly/chemotherapy
  • Unresectable primary cancer
  • Palliative surgery

Collaborators and Investigators

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


    • PRINCIPAL_INVESTIGATOR: Dong Sup Yoon, MD,PhD, Yonsei University

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available