NCT00809081

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. 1.To evaluate whether early enteral nutrition may be a suitable alternative to total parenteral nutrition
  2. 2.To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 16, 2008

Status Verified

December 1, 2008

Enrollment Period

1.9 years

First QC Date

December 15, 2008

Last Update Submit

December 15, 2008

Conditions

Pancreas CancerBile Duct CancerAmpulla of Vater Cancer

Keywords

periampullar carcinomaPancreaticoduodenectomyEnteral feedingTotal Parenteral Support

Outcome Measures

Primary Outcomes (1)

  • To evaluate the impact of early postoperative enteral feeding

    Postoperative 21 days

Secondary Outcomes (1)

  • To evaluate the nutritional status

    Postoperative 6 months

Study Arms (2)

1

OTHER

1\. Enteral Feeding

Procedure: Enteral Feeding and Total Parental Support

2

NO INTERVENTION

Total Parental support

Procedure: Enteral Feeding and Total Parental Support

Interventions

Enteral Feeding and Total Parental SupportPROCEDURE

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

Also known as: Total Parental support: 1000 kcal /d on POD 1, : Velocity is progressively increased by 20ml/d, until full nutritional goal (25Kcal/Kg)
12

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yongdong Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsBile Duct Neoplasms

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Dong Sup Yoon, MD,PhD

    Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2008

First Posted

December 16, 2008

Study Start

July 1, 2007

Primary Completion

June 1, 2009

Study Completion

January 1, 2010

Last Updated

December 16, 2008

Record last verified: 2008-12

Locations

KR(1)