Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy (EPIPD)

Chiba University

Status and phase: Completed; Phase 4

Conditions: Bile Duct Cancer; Pancreatic Cancer

Treatments: Dietary Supplement: Oral IMPACT

Study type: Interventional

Funder types: Other

Identifiers

NCT01256034

furukawa2009

Details and patient eligibility

About

The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with pancreaticoduodenectomy.

Full description

The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after pancreaticoduodenectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect.

Object of this study is to investigate the effects preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after pancreaticoduodenectomy.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients underwent pancreaticoduodenectomy

Exclusion criteria

• age younger than 18 years
• ongoing infection
• gastrointestinal obstruction
• respiratory dysfunction
• cardiac dysfunction
• hepatic dysfunction
• renal failure
• history of recent immunosuppressive or immunological diseases
• preoperative evidence of widespread metastatic disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Group A

Active Comparator group

Description:

preoperative immunonutrition

Treatment:

Dietary Supplement: Oral IMPACT

Group B

No Intervention group

Description:

ordinary diet