Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00809081
First received: December 15, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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 Intervention Phase
Pancreas Cancer
Bile Duct Cancer
Ampulla of Vater Cancer
Procedure: Enteral Feeding and Total Parental Support
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial of Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • To evaluate the impact of early postoperative enteral feeding [ Time Frame: Postoperative 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the nutritional status [ Time Frame: Postoperative 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: July 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809081

Locations
Korea, Republic of
Yongdong Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dong Sup Yoon, MD, PhD    +82-2-2019-2444    yds6110@yuhs.ac   
Contact: Joon Seong Park, MD    +82-2-2019-3375    jspark330@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Dong Sup Yoon, MD,PhD Yonsei University
  More Information

No publications provided

Responsible Party: Dong Sup Yoon/Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT00809081     History of Changes
Other Study ID Numbers: EN Vs PN
Study First Received: December 15, 2008
Last Updated: December 15, 2008
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
periampullar carcinoma
Pancreaticoduodenectomy
Enteral feeding
Total Parenteral Support

Additional relevant MeSH terms:
Pancreatic Neoplasms
Bile Duct Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on July 28, 2014