Trial Outcomes & Findings for Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy (NCT NCT01256034)

NCT ID: NCT01256034

Last Updated: 2012-10-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2012-10-23

Participant Flow

Participant milestones

Measure	Group A preoperative immunonutrition	Group B ordinary diet
Overall Study STARTED	25	25
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	25	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Baseline characteristics by cohort

Measure	Group A n=25 Participants preoperative immunonutrition	Group B n=25 Participants ordinary diet	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Age Continuous	66.4 years STANDARD_DEVIATION 7.5 • n=5 Participants	65.1 years STANDARD_DEVIATION 9.5 • n=7 Participants	65.8 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment Japan	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Measure	Group A n=25 Participants preoperative immunonutrition	Group B n=25 Participants ordinary diet
Postoperative Infectious Complication	7 participants	15 participants

SECONDARY outcome

Timeframe: 14 days

Outcome measures

Outcome data not reported

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Katsunori Furukawa

Chiba University Graduate School of Medicine

Phone: +81-43-226-2269

Email: k-furukawa@umin.ac.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place