Early Enteral Feeding After Pylorus Preserving Pancreatod... | NCT00809081

Studies
Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

NCT00809081

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Dec 16, 2008Estimated

Enrollment

38Estimated

Phase

Phase 3

Conditions

Pancreas Cancer
Bile Duct Cancer
Ampulla of Vater Cancer

Interventions

Enteral Feeding and Total Parental Support

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Jun 2009Estimated

Completion Date

Jan 2010Estimated

First Submitted Date

Dec 15, 2008

First Submission Date that Met QC Criteria

Dec 15, 2008

First Posted Date

Dec 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2008

Last Update Posted Date

Dec 16, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Enteral Feeding and Total Parental Support	Procedure	Enteral Feeding : 20ml/hr on POD1 Velocity is progressively increased by 20ml/d until full nutritional goal (25Kcal/Kg)	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the nutritional status		Postoperative 6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dong Sup Yoon, MD,PhD	Yonsei University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yongdong Severance Hospital	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms
D001650	Bile Duct Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004750	Enteral Nutrition

Ancestor Terms

ID	Term
D005248	Feeding Methods
D013812	Therapeutics
D018529	Nutritional Support
D044623	Nutrition Therapy

Browse Leaves

Not provided

Browse Branches

Not provided