Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Chiba University

Status and phase: Unknown; Phase 4

Conditions: Pancreatic Tumor; Bile Duct Tumor

Treatments: Dietary Supplement: Oral IMPACT

Study type: Interventional

Funder types: Other

Identifiers

NCT01969110

AEPIPD

Details and patient eligibility

About

The purpose of this study is to investigate whether perioperative immunonutrition has additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy.

Full description

The investigators reported that perioperative immunonutrition had no additional effects compared with preoperative immunonutrition in patients underwent colorectal surgery (Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002; 132:805-14, PMID: 12464864). Object of this study is to investigate the additional effects of perioperative immunonutrition on cell-mediated immunity and incidence of infectious complication after pancreaticoduodenectomy.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing pancreaticoduodenectomy

Exclusion criteria

• age younger than 18 years old
• ongoing infection
• gastrointestinal obstruction
• respiratory dysfunction
• cardiac dysfunction
• hepatic dysfunction
• renal failure
• history of recent immunosuppressive or immunological disease
• 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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60 participants in 2 patient groups

Perioperative

Active Comparator group

Description:

Oral IMPACT (1 L/day) for 5 days before surgery and by enteral feeding after surgery

Treatment:

Dietary Supplement: Oral IMPACT

Preoperative

Active Comparator group

Description:

Oral IMPACT 1000ml/day for 5 days (1 L/day) before surgery

Treatment:

Dietary Supplement: Oral IMPACT