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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

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

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=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
n=99 Participants
11 Participants
n=107 Participants
20 Participants
n=206 Participants
Age, Categorical
>=65 years
16 Participants
n=99 Participants
14 Participants
n=107 Participants
30 Participants
n=206 Participants
Age Continuous
66.4 years
STANDARD_DEVIATION 7.5 • n=99 Participants
65.1 years
STANDARD_DEVIATION 9.5 • n=107 Participants
65.8 years
STANDARD_DEVIATION 8.5 • n=206 Participants
Sex: Female, Male
Female
5 Participants
n=99 Participants
9 Participants
n=107 Participants
14 Participants
n=206 Participants
Sex: Female, Male
Male
20 Participants
n=99 Participants
16 Participants
n=107 Participants
36 Participants
n=206 Participants
Region of Enrollment
Japan
25 participants
n=99 Participants
25 participants
n=107 Participants
50 participants
n=206 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

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

Results disclosure agreements

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