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A Prospective, Randomized Trial of Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy


Phase 3
18 Years
85 Years
Open (Enrolling)
Both
Pancreas Cancer, Bile Duct Cancer, Ampulla of Vater Cancer

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Trial Information

A Prospective, Randomized Trial of Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

To evaluate the impact of early postoperative enteral feeding

Outcome Time Frame:

Postoperative 21 days

Safety Issue:

No

Principal Investigator

Dong Sup Yoon, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yonsei University

Authority:

South Korea: Institutional Review Board

Study ID:

EN Vs PN

NCT ID:

NCT00809081

Start Date:

July 2007

Completion Date:

January 2010

Related Keywords:

  • Pancreas Cancer
  • Bile Duct Cancer
  • Ampulla of Vater Cancer
  • periampullar carcinoma
  • Pancreaticoduodenectomy
  • Enteral feeding
  • Total Parenteral Support
  • Pancreatic Neoplasms
  • Bile Duct Neoplasms

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