Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

Yonsei University

Status and phase: Unknown; Phase 3

Conditions: Ampulla of Vater Cancer; Bile Duct Cancer; Pancreas Cancer

Treatments: Procedure: Enteral Feeding and Total Parental Support

Study type: Interventional

Funder types: Other

Identifiers

NCT00809081

EN Vs PN

Details and patient eligibility

About

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

Full 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.

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

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

1

Other group

Description:

1. Enteral Feeding

Treatment:

Procedure: Enteral Feeding and Total Parental Support

2

No Intervention group

Description:

Total Parental support

Treatment:

Procedure: Enteral Feeding and Total Parental Support