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Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

Primary Purpose

Pancreas Cancer, Bile Duct Cancer, Ampulla of Vater Cancer

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Enteral Feeding and Total Parental Support
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring periampullar carcinoma, Pancreaticoduodenectomy, Enteral feeding, Total Parenteral Support

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yongdong Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

1

2

Arm Description

1. Enteral Feeding

Total Parental support

Outcomes

Primary Outcome Measures

To evaluate the impact of early postoperative enteral feeding

Secondary Outcome Measures

To evaluate the nutritional status

Full Information

First Posted
December 15, 2008
Last Updated
December 15, 2008
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT00809081
Brief Title
Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy
Official Title
A Prospective, Randomized Trial of Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. 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. To evaluate whether early enteral nutrition may be a suitable alternative to total parenteral nutrition To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy
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. To evaluate whether early enteral nutrition may be decreased the postoperative complications To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy To determine the optimal method for postoperative nutritional support

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Bile Duct Cancer, Ampulla of Vater Cancer
Keywords
periampullar carcinoma, Pancreaticoduodenectomy, Enteral feeding, Total Parenteral Support

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
1. Enteral Feeding
Arm Title
2
Arm Type
No Intervention
Arm Description
Total Parental support
Intervention Type
Procedure
Intervention Name(s)
Enteral Feeding and Total Parental Support
Other Intervention Name(s)
Total Parental support: 1000 kcal /d on POD 1, : Velocity is progressively increased by 20ml/d, until full nutritional goal (25Kcal/Kg)
Intervention Description
Enteral Feeding : 20ml/hr on POD1 Velocity is progressively increased by 20ml/d until full nutritional goal (25Kcal/Kg)
Primary Outcome Measure Information:
Title
To evaluate the impact of early postoperative enteral feeding
Time Frame
Postoperative 21 days
Secondary Outcome Measure Information:
Title
To evaluate the nutritional status
Time Frame
Postoperative 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Sup Yoon, MD,PhD
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yongdong Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Sup Yoon, MD, PhD
Phone
+82-2-2019-2444
Email
yds6110@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Joon Seong Park, MD
Phone
+82-2-2019-3375
Email
jspark330@yuhs.ac

12. IPD Sharing Statement

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Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

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