PancreaticoduodenectomyPhase 4NCT00668876
Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
A Phase 4 study testing Oral IMPACT and Parenteral nutrition in people with Pancreaticoduodenectomy, run by Chiba University at 1 site in Japan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreaticoduodenectomy
- What is being tested?
- Oral IMPACT and Parenteral nutrition
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- May 2006to Sep 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients underwent pancreaticoduodenectomy
Who cannot join
- age younger than 18 years or older than 75 years
- preoperative chemotherapy or radiation
- ongoing infection
- diabetes mellitus
- gastrointestinal obstruction
- respiratory dysfunction
Show all 11Show fewer
- cardiac dysfunction
- hepatic dysfunction
- renal failure
- history of recent immunosuppressive or immunological diseases
- preoperative evidence of widespread metastatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Immunonutrition on Surgical Site Infection and Th1/Th2/Th17 Differentiation in Patients Undergoing Pancreaticoduodenectomy
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
Read the detailed 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.
- Conditions
- Pancreaticoduodenectomy
- Being tested
- Oral IMPACT, Parenteral nutrition
- Keywords
- immunonutrition, pancreaticoduodenectomy, Th1, Th2, Th17
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral IMPACTDietary supplement
Also called oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
oral supplementation for 5 days(1 L/d )before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
Oral IMPACTDietary supplement
postoperative enteral infusion of the formula with arginine, omega-3 fatty acids, and RNA
Parenteral nutritionDietary supplement
Parenteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Group A: perioperative immunonutrition Receives: Dietary Supplement: Oral IMPACT |
| 2 | Active comparator | Group B: postoperative immunonutrition Receives: Dietary Supplement: Oral IMPACT |
| 3 | Active comparator | Group C: control Receives: Dietary Supplement: Parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical site infection after surgery
Measured: 30days
Secondary outcomes (1)
plasma IL-6, CRP, Th1/Th2 balance, Th17 status
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startMay 2006
- Primary completionJan 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreaticoduodenectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiba University
- Sponsor type
- University, hospital or other
- Investigators
- Daisuke Suzuki, Principal investigator, Chiba University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668876
- Sponsor's protocol ID
- furukawa2008
- Status last verified
- Oct 2008
- First submitted
- 28 Apr 2008
- Last updated
- 3 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Immunonutrition on Surgical Site Infection and Th1/Th2/Th17 Differentiation in Patients Undergoing Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT00668876
- Acronym / sponsor ID
- furukawa2008
- Conditions
- Pancreaticoduodenectomy
- Keywords
- immunonutrition, pancreaticoduodenectomy, Th1, Th2, Th17
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chiba UniversityUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Oral IMPACTGroup A: perioperative immunonutrition |
| 2 | Active comparator | Dietary Supplement: Oral IMPACTGroup B: postoperative immunonutrition |
| 3 | Active comparator | Dietary Supplement: Parenteral nutritionGroup C: control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients underwent pancreaticoduodenectomy
Key exclusion criteria (11 listed)
- age younger than 18 years or older than 75 years
- preoperative chemotherapy or radiation
- ongoing infection
- diabetes mellitus
- gastrointestinal obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral IMPACTAlso: oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japanoral supplementation for 5 days(1 L/d )before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA | Dietary supplement | 1 |
| Oral IMPACTpostoperative enteral infusion of the formula with arginine, omega-3 fatty acids, and RNA | Dietary supplement | 2 |
| Parenteral nutritionParenteral nutrition | Dietary supplement | 3 |
Primary outcome
surgical site infection after surgery
Time frame: 30days
1 secondary outcome
plasma IL-6, CRP, Th1/Th2 balance, Th17 status
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daisuke Suzuki principal investigator
Chiba University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral IMPACT and Parenteral nutrition in people with Pancreaticoduodenectomy, run by Chiba University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical site infection after surgery (time frame: 30days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2008.