Clincosm LogoSign in Get a demo

Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

Sponsor
Yonsei University (Other)
Overall Status
Unknown status
CT.gov ID
NCT00809081
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
30.1
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Enteral Feeding and Total Parental Support
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized Trial of Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy
Study Start Date :
Jul 1, 2007
Anticipated Primary Completion Date :
Jun 1, 2009
Anticipated Study Completion Date :
Jan 1, 2010

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the impact of early postoperative enteral feeding [Postoperative 21 days]

    Secondary Outcome Measures

    1. To evaluate the nutritional status [Postoperative 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yongdong Severance Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00809081
    Other Study ID Numbers:
    • EN Vs PN
    First Posted:
    Dec 16, 2008
    Last Update Posted:
    Dec 16, 2008
    Last Verified:
    Dec 1, 2008
    Keywords provided by , ,
    periampullar carcinoma
    Pancreaticoduodenectomy
    Enteral feeding
    Total Parenteral Support
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Bile Duct Neoplasms
    Cholangiocarcinoma

    Study Results

    No Results Posted as of Dec 16, 2008