Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

December 15, 2008 updated by: Yonsei University

A Prospective, Randomized Trial of 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Phase 3

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

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Yongdong Severance Hospital
        • Contact:
          • Dong Sup Yoon, MD, PhD
          • Phone Number: +82-2-2019-2444
          • Email: yds6110@yuhs.ac
        • Contact:

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 to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / 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)
Other Names:
  • Total Parental support: 1000 kcal /d on POD 1
  • : 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)
Other Names:
  • Total Parental support: 1000 kcal /d on POD 1
  • : Velocity is progressively increased by 20ml/d
  • until full nutritional goal (25Kcal/Kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the impact of early postoperative enteral feeding
Time Frame: Postoperative 21 days
Postoperative 21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the nutritional status
Time Frame: Postoperative 6 months
Postoperative 6 months

Collaborators and Investigators

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

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Dong Sup Yoon, MD,PhD, Yonsei University

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

July 1, 2007

Primary Completion (ANTICIPATED)

June 1, 2009

Study Completion (ANTICIPATED)

January 1, 2010

Study Registration Dates

First Submitted

December 15, 2008

First Submitted That Met QC Criteria

December 15, 2008

First Posted (ESTIMATE)

December 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 16, 2008

Last Update Submitted That Met QC Criteria

December 15, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EN Vs PN

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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