Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

Phase 3

• Conditions: Pancreas Cancer; Bile Duct Cancer; Ampulla of Vater Cancer
• Interventions: Procedure: Enteral Feeding and Total Parental Support

• Registration Number: NCT00809081
• Lead Sponsor: Yonsei University

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.

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

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

Study Timeline

• Study Start: 2007-07
• Status Verified: 2008-12
• Study First Submitted: 2008-12-15
• Study First Submitted QC: 2008-12-15
• Last Update Submitted: 2008-12-15
• Study First Posted: 2008-12-16
• Last Update Posted: 2008-12-16
• Primary Completion: 2009-06
• Study Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Enteral Feeding and Total Parental Support	1. Enteral Feeding
2	Enteral Feeding and Total Parental Support	Total Parental support

Primary Outcome Measures

Name	Time	Method
To evaluate the impact of early postoperative enteral feeding	Postoperative 21 days

Secondary Outcome Measures

Name	Time	Method
To evaluate the nutritional status	Postoperative 6 months

Trial Locations

Locations (1)

Yongdong Severance Hospital; 🇰🇷 Seoul, Korea, Republic of