Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Chiba University

Status and phase: Completed; Phase 4

Conditions: Pancreaticoduodenectomy

Treatments: Dietary Supplement: Oral IMPACT; Dietary Supplement: Parenteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT00668876

furukawa2008

Details and patient eligibility

About

The purpose of this study is to determine whether immunonutrition is effective on surgical site infection and Th1/Th2/Th17 differentiation in patients undergoing pancreaticoduodenectomy

Full description

Perioperative immunonutrition is reported to improve the incidence of postoperative infectious complication in patients with gastrointestinal surgery. It has also been recognized that Th1/Th2 balance shifts toward Th2 by surgical stress. On the other hand, the change of Th17 status after surgery has not been established. Furthermore, The change of Th1/Th2 balance and Th17 status with immunonutrition on pancreaticoduodenectomy have not been reported yet.

Objective of this study is to investigate the effects of perioperative immunonutrition on incidence of postoperative infectious complication, Th1/Th2 balance and Th17 status after pancreaticoduodenectomy.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients underwent pancreaticoduodenectomy

Exclusion criteria

• age younger than 18 years or older than 75 years
• preoperative chemotherapy or radiation
• ongoing infection
• diabetes mellitus
• 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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30 participants in 3 patient groups

1

Active Comparator group

Description:

Group A: perioperative immunonutrition

Treatment:

Dietary Supplement: Oral IMPACT

Dietary Supplement: Oral IMPACT

2

Active Comparator group

Description:

Group B: postoperative immunonutrition

Treatment:

Dietary Supplement: Oral IMPACT

Dietary Supplement: Oral IMPACT

3

Active Comparator group

Description:

Group C: control

Treatment:

Dietary Supplement: Parenteral nutrition