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CompletedNCT06555510Updated Aug 15, 2024

Preoperative Edema is a Significant Risk Factor for Post-hepatectomy Complications

An observational study in Patients Who Underwent Hepatectomy for Liver Neoplasms, sponsored by Kochi University. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Kochi University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
414
Sex
All
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Study 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.

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.

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Conditions studied

  • Patients Who Underwent Hepatectomy for Liver Neoplasms

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In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's enrollment of 414 is above the median of 200 across 350 observational studies indexed under Liver Neoplasms.

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Lead sponsor

Kochi University is the lead sponsor of 18 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • clinical diagnosis of liver neoplasms

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
414 participants (actual)
Patient registry
No

Interventions

  • OtherInBody

    Bioelectrical impedance analysis

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What researchers measure

Primary outcomes

  1. incidence of post-hepatectomy complications

    through study completion, 1year

    Time frame: incidence of post-hepatectomy complications

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Study locations

1 site
  • Takehiro Okabayashi
    Kochi, 781-8555, Japan
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06555510
Lead sponsor
Kochi University
Responsible party
Takehiro Okabayashi (Head of Gastroenterological Surgery, Kochi University) — Principal investigator
First posted
Aug 15, 2024
Start date
Jan 1, 2023
Primary completion
Jun 30, 2023
Completion
Dec 31, 2023
Last update
Aug 15, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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