CancerNCT05257434
Postoperative Outcomes in Patients With Hepato-biliary-pancreatic Cancer According to inBody Test
An observational study of Cancer, run by Kochi University at 1 site in Japan.
Trial summary
postoperative outcomes were evaluated by using inBody test Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer
- What is being tested?
- inbody
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jan 2019to 31 Jan 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: surgically treated patients who were suffering from hepato-biliary-pancreatic cancer
Who may be able to join
- surgically treated patients
Who cannot join
- a body weight loss of >10% during the 6 months before surgery; the presence of distant metastases; or seriously impaired function of vital organs because of respiratory, renal, or heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Takehiro Okabayashi
Kochi, 781-8555
Takehiro Okabayashi, +81- 88-837-3000, tokabaya@gmail.com
About this study
postoperative outcomes were evaluated by using inBody test
Read the detailed description
postoperative outcomes were evaluated by using inBody test
- Conditions
- Cancer
- Being tested
- inbody
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inbodyBehavioural
Body fluid composition
What is being measured
The primary outcome is the main question the study is designed to answer.
long-term outcomes
overall survival rate
Measured: 5year
Secondary outcomes (1)
short-term outcomes
postoperative complications
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Jan 2019
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2030 (estimated)
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Kochi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takehiro Okabayashi, Kochi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257434
- Sponsor's protocol ID
- Point study
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kimura J, Sui K, Tabuchi M, Sakamoto S, Murokawa T, Iwata J, Morita S, Iiyama T, Okabayashi T. Preoperative percent body fat in bioelectrical impedance analysis predicts pancreatic fistula after pancreaticoduodenectomy. Langenbecks Arch Surg. 2023 Jun 28;408(1):248. doi: 10.1007/s00423-023-02998-y.
PubMed 37380749
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Outcomes in Patients With Hepato-biliary-pancreatic Cancer According to inBody Test
- ClinicalTrials.gov ID
- NCT05257434
- Acronym / sponsor ID
- Point study
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Kochi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 25 Feb 2022 (actual)
- 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.
postoperative outcomes were evaluated by using inBody test
Detailed description
postoperative outcomes were evaluated by using inBody test
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- surgically treated patients who were suffering from hepato-biliary-pancreatic cancer
Key inclusion criteria (1 listed)
- surgically treated patients
Key exclusion criteria (1 listed)
- a body weight loss of >10% during the 6 months before surgery; the presence of distant metastases; or seriously impaired function of vital organs because of respiratory, renal, or heart disease
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 |
|---|---|---|
| inbodyBody fluid composition | Behavioural | – |
Primary outcome
long-term outcomes
Time frame: 5year
overall survival rate
1 secondary outcome
short-term outcomes
Time frame: up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Derived from this study: PubMed 37380749Kimura J, Sui K, Tabuchi M, Sakamoto S, Murokawa T, Iwata J, Morita S, Iiyama T, Okabayashi T. Preoperative percent body fat in bioelectrical impedance analysis predicts pancreatic fistula after pancreaticoduodenectomy. Langenbecks Arch Surg. 2023 Jun 28;408(1):248. doi: 10.1007/s00423-023-02998-y.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Kochi 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 1 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: looking for participants now, as of the sponsor's last update on 25 Feb 2022. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long-term outcomes (time frame: 5year). 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 NCT05257434, 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 25 Feb 2022.