Patients Who Underwent Hepatectomy for Liver NeoplasmsNCT06555510
Preoperative Edema is a Significant Risk Factor for Post-hepatectomy Complications
An observational study of Patients Who Underwent Hepatectomy for Liver Neoplasms, run by Kochi University at 1 site in Japan.
Trial summary
Aims: The relationship between bioelectrical impedance analysis (BIA) results and post-hepatectomy complications is unknown. This study aimed to identify the risk factors for post-hepatectomy complications from the BIA results. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients Who Underwent Hepatectomy for Liver Neoplasms
- What is being tested?
- InBody
- How many people
- 414 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We prospectively reviewed consecutive patients who underwent hepatectomy at the Kochi Health Sciences Center. Patients who underwent hepatectomy, regardless of the underlying disease, between March 2018 and December 2022 were eligible for the study. Patients who did not undergo preoperative BIA were excluded. Those who underwent repeat hepatectomies were included; however, if they underwent more than two hepatectomies in the study period, only the clinical features during the first hepatectomy period were included and those during the second or third hepatectomy period were excluded.
Who may be able to join
- clinical diagnosis of liver neoplasms
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.
About this study
Official title: Preoperative Edema is a Significant Risk Factor for Post-hepatectomy Complications Regardless of the Underlying Disease.
Aims: The relationship between bioelectrical impedance analysis (BIA) results and post-hepatectomy complications is unknown. This study aimed to identify the risk factors for post-hepatectomy complications from the BIA results.
Methods: This prospective, observational cohort study reviewed the data of patients who underwent hepatectomy between March 2018 and December 2022. The patients were matched using the following propensity score covariates: biliary enteric anastomosis and major hepatectomy. Risk factors for postoperative complications were investigated in a matched cohort.
- Being tested
- InBody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InBodyOther
Bioelectrical impedance analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of post-hepatectomy complications
through study completion, 1year
Measured: incidence of post-hepatectomy complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Who Underwent Hepatectomy for Liver NeoplasmsStudies 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
- 414 participants (actual)
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
- NCT06555510
- Sponsor's protocol ID
- KHSC2401
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Edema is a Significant Risk Factor for Post-hepatectomy Complications Regardless of the Underlying Disease.
- ClinicalTrials.gov ID
- NCT06555510
- Acronym / sponsor ID
- KHSC2401
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Kochi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 Aug 2024 (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.
Aims: The relationship between bioelectrical impedance analysis (BIA) results and post-hepatectomy complications is unknown. This study aimed to identify the risk factors for post-hepatectomy complications from the BIA results.
Methods: This prospective, observational cohort study reviewed the data of patients who underwent hepatectomy between March 2018 and December 2022. The patients were matched using the following propensity score covariates: biliary enteric anastomosis and major hepatectomy. Risk factors for postoperative complications were investigated in a matched cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We prospectively reviewed consecutive patients who underwent hepatectomy at the Kochi Health Sciences Center. Patients who underwent hepatectomy, regardless of the underlying disease, between March 2018 and December 2022 were eligible for the study. Patients who did not undergo preoperative BIA were excluded. Those who underwent repeat hepatectomies were included; however, if they underwent more than two hepatectomies in the study period, only the clinical features during the first hepatectomy period were included and those during the second or third hepatectomy period were excluded.
Key inclusion criteria (1 listed)
- clinical diagnosis of liver neoplasms
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 |
|---|---|---|
| InBodyBioelectrical impedance analysis | Other | – |
Primary outcome
incidence of post-hepatectomy complications
Time frame: incidence of post-hepatectomy complications
through study completion, 1year
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 15 Aug 2024.
Related trials for Patients Who Underwent Hepatectomy for Liver Neoplasms
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Patients Who Underwent Hepatectomy for Liver Neoplasms, 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: finished, as of the sponsor's last update on 15 Aug 2024. 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?
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?
incidence of post-hepatectomy complications (time frame: incidence of post-hepatectomy complications). 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 15 Aug 2024.