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Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

NCT ID: NCT00809081

Last Updated: 2008-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-01-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Pancreas Cancer Bile Duct Cancer Ampulla of Vater Cancer

Keywords

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periampullar carcinoma Pancreaticoduodenectomy Enteral feeding Total Parenteral Support

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

1\. Enteral Feeding

Group Type OTHER

Enteral Feeding and Total Parental Support

Intervention Type PROCEDURE

Enteral Feeding : 20ml/hr on POD1

* Velocity is progressively increased by 20ml/d until full nutritional goal (25Kcal/Kg)

2

Total Parental support

Group Type NO_INTERVENTION

Enteral Feeding and Total Parental Support

Intervention Type PROCEDURE

Enteral Feeding : 20ml/hr on POD1

* Velocity is progressively increased by 20ml/d until full nutritional goal (25Kcal/Kg)

Interventions

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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)

Intervention Type PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Yonsei University

Principal Investigators

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Dong Sup Yoon, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

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Yongdong Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Dong Sup Yoon, MD, PhD

Role: primary

Joon Seong Park, MD

Role: backup

Other Identifiers

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EN Vs PN

Identifier Type: -

Identifier Source: org_study_id