Pancreatic TumorPhase 4NCT01969110
Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
A Phase 4 study testing Oral IMPACT in people with Pancreatic Tumor and Bile Duct Tumor, run by Chiba University at 1 site in Japan.
Trial summary
The purpose of this study is to investigate whether perioperative immunonutrition has additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Tumor, Bile Duct Tumor
- What is being tested?
- Oral IMPACT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2013to Sep 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing pancreaticoduodenectomy
Who cannot join
- age younger than 18 years old
- ongoing infection
- gastrointestinal obstruction
- respiratory dysfunction
- cardiac dysfunction
- hepatic dysfunction
Show all 9Show fewer
- renal failure
- history of recent immunosuppressive or immunological disease
- preoperative evidence of widespread metastatic disease
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Chiba University Hospital
Chiba, Chiba, 260-8670
Katsunori Furukawa, MD, +81-43-222-7171 ext. 72235, k-furukawa@umin.ac.jp
About this study
Official title: Additional Effects of Perioperative Immunonutrition on Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy
The purpose of this study is to investigate whether perioperative immunonutrition has additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy.
Read the detailed 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.
- Conditions
- Pancreatic Tumor, Bile Duct Tumor
- Being tested
- Oral IMPACT
- Keywords
- Immunonutrition
- Medical subject headings
- Pancreatic Neoplasms, Bile Duct Neoplasms
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 IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery
| Study group | Role | What they receive |
|---|---|---|
| Perioperative | Active comparator | Oral IMPACT (1 L/day) for 5 days before surgery and by enteral feeding after surgery Receives: Dietary Supplement: Oral IMPACT |
| Preoperative | Active comparator | Oral IMPACT 1000ml/day for 5 days (1 L/day) before surgery Receives: Dietary Supplement: Oral IMPACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma resolvin E1, cell-mediated immunity
Measured: 30 days
Secondary outcomes (1)
infectious complication rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic TumorStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiba University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katsunori Furukawa, Chiba University
- Investigators
- Katsunori Furukawa, MD, Study director, Chiba University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969110
- Sponsor's protocol ID
- AEPIPD
- Status last verified
- Oct 2013
- First submitted
- 5 Oct 2013
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Perioperative Immunonutrition on Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT01969110
- Acronym / sponsor ID
- AEPIPD
- Conditions
- Pancreatic Tumor, Bile Duct Tumor
- Keywords
- Immunonutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chiba UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 25 Oct 2013 (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 investigate whether perioperative immunonutrition has additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perioperative | Active comparator | Dietary Supplement: Oral IMPACTOral IMPACT (1 L/day) for 5 days before surgery and by enteral feeding after surgery |
| Preoperative | Active comparator | Dietary Supplement: Oral IMPACTOral IMPACT 1000ml/day for 5 days (1 L/day) before surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing pancreaticoduodenectomy
Key exclusion criteria (9 listed)
- age younger than 18 years old
- ongoing infection
- gastrointestinal obstruction
- respiratory dysfunction
- cardiac dysfunction
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 IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery | Dietary supplement | Perioperative, Preoperative |
Primary outcome
plasma resolvin E1, cell-mediated immunity
Time frame: 30 days
1 secondary outcome
infectious complication rate
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
Related trials for Pancreatic Tumor
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Katsunori Furukawa, MD study director
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 in people with Pancreatic Tumor and Bile Duct Tumor, 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 9 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: status not confirmed, as of the sponsor's last update on 25 Oct 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katsunori Furukawa, MD (+81-43-222-7171 ext. 72235, k-furukawa@umin.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma resolvin E1, cell-mediated immunity (time frame: 30 days). 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 25 Oct 2013.