Bile Duct CancerPhase 4NCT01256047
Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy
A Phase 4 study testing Oral IMPACT in people with Bile Duct Cancer, run by Chiba University at 1 site in Japan.
Trial summary
The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with major hepatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Cancer
- 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
- 40 participants
- Where
- 1 siteJapan
- Study dates
- May 2009to Mar 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hepatectomy
Who cannot join
- age younger than 18 years
- 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.
About this study
Official title: Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Hepatectomy
The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with major hepatectomy.
Read the detailed description
The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after hepatectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect.
Object of this study is to investigate the effects of preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after hepatectomy.
- Conditions
- Bile Duct Cancer
- Being tested
- Oral IMPACT
- Keywords
- immunonutrition, hepatectomy, Th1, Th2
- Medical subject headings
- 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 supplement for 5 days(1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | preoperative immunonutrition Receives: Dietary Supplement: Oral IMPACT |
| group B | No intervention | ordinary diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative infectious complication
Measured: 30 days
Secondary outcomes (1)
plasma IL-6, CRP, Th1/Th2 balance
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 posted8 Dec 2010 (estimated)
- Study startMay 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bile Duct CancerStudies 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
- 40 participants (actual)
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
- NCT01256047
- Sponsor's protocol ID
- furukawa2009-2
- Status last verified
- Feb 2020
- First submitted
- 7 Dec 2010
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Uno H, Furukawa K, Suzuki D, Shimizu H, Ohtsuka M, Kato A, Yoshitomi H, Miyazaki M. Immunonutrition suppresses acute inflammatory responses through modulation of resolvin E1 in patients undergoing major hepatobiliary resection. Surgery. 2016 Jul;160(1):228-236. doi: 10.1016/j.surg.2016.01.019. Epub 2016 Mar 8.
PubMed 26965712
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Hepatectomy
- ClinicalTrials.gov ID
- NCT01256047
- Acronym / sponsor ID
- furukawa2009-2
- Conditions
- Bile Duct Cancer
- Keywords
- immunonutrition, hepatectomy, Th1, Th2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chiba UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Dec 2010 (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 preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with major hepatectomy.
Detailed description
The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after hepatectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect.
Object of this study is to investigate the effects of preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after hepatectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Dietary Supplement: Oral IMPACTpreoperative immunonutrition |
| group B | No intervention | –ordinary diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hepatectomy
Key exclusion criteria (9 listed)
- age younger than 18 years
- 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 supplement for 5 days(1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA | Dietary supplement | group A |
Primary outcome
postoperative infectious complication
Time frame: 30 days
1 secondary outcome
plasma IL-6, CRP, Th1/Th2 balance
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 18 Feb 2020.
- Derived from this study: PubMed 26965712Uno H, Furukawa K, Suzuki D, Shimizu H, Ohtsuka M, Kato A, Yoshitomi H, Miyazaki M. Immunonutrition suppresses acute inflammatory responses through modulation of resolvin E1 in patients undergoing major hepatobiliary resection. Surgery. 2016 Jul;160(1):228-236. doi: 10.1016/j.surg.2016.01.019. Epub 2016 Mar 8.
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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.
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 Bile Duct Cancer, 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: finished, as of the sponsor's last update on 18 Feb 2020. 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?
postoperative infectious complication (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01256047, which also lists 1 linked publication.
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 18 Feb 2020.