NCT01969110

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

2.7 years

First QC Date

October 5, 2013

Last Update Submit

October 24, 2013

Conditions

Pancreatic TumorBile Duct Tumor

Keywords

Immunonutrition

Outcome Measures

Primary Outcomes (1)

  • plasma resolvin E1, cell-mediated immunity

    30 days

Secondary Outcomes (1)

  • infectious complication rate

    30 days

Study Arms (2)

Perioperative

ACTIVE COMPARATOR

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

Dietary Supplement: Oral IMPACT

Preoperative

ACTIVE COMPARATOR

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

Dietary Supplement: Oral IMPACT

Interventions

Oral IMPACTDIETARY_SUPPLEMENT

Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery

Also known as: Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
PerioperativePreoperative

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing pancreaticoduodenectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiba University Hospital

Chiba, Chiba, 260-8670, Japan

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsBile Duct Neoplasms

Interventions

Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract Diseases

Intervention Hierarchy (Ancestors)

Neuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Katsunori Furukawa, MD

    Chiba University

    STUDY DIRECTOR

Central Study Contacts

Katsunori Furukawa, MD

CONTACT

+81-43-222-7171k-furukawa@umin.ac.jp

Daisuke Suzuki, MD

CONTACT

+81-43-222-7171d-suzuki@umin.ac.jp

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 5, 2013

First Posted

October 25, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 25, 2013

Record last verified: 2013-10

Locations

JP(1)