Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

Pancreas Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00809081
• Other study ID #: EN Vs PN
• Status: Recruiting
• Phase: Phase 3
• First received: December 15, 2008
• Last updated: December 15, 2008
• Start date: July 2007
• Est. completion date: January 2010

Study information

• Verified date: December 2008
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: January 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Ampulla of Vater Cancer
• Bile Duct Cancer
• Cholangiocarcinoma
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Yongdong Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the impact of early postoperative enteral feeding		Postoperative 21 days	No
Secondary	To evaluate the nutritional status		Postoperative 6 months	No