UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061803 |
|---|---|
| Receipt number | R000070722 |
| Scientific Title | The Impact of Hospital Surgical Volumes on Short-Term Outcomes Following Brain Tumor Surgery from a Nationwide Database in Japan |
| Date of disclosure of the study information | 2026/06/05 |
| Last modified on | 2026/06/04 20:09:47 |
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Basic information
Public title
The Impact of Hospital Surgical Volumes on Short-Term Outcomes Following Brain Tumor Surgery from a Nationwide Database in Japan
Acronym
The Impact of Hospital Surgical Volumes on Short-Term Outcomes Following Brain Tumor Surgery from a Nationwide Database in Japan
Scientific Title
The Impact of Hospital Surgical Volumes on Short-Term Outcomes Following Brain Tumor Surgery from a Nationwide Database in Japan
Scientific Title:Acronym
The Impact of Hospital Surgical Volumes on Short-Term Outcomes Following Brain Tumor Surgery from a Nationwide Database in Japan
Region
| Japan |
Condition
Condition
Central Nervous System Tumors
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The literature suggests that patients with brain tumors show better prognoses when treated at hospitals with high surgical volumes, and this is considered one of the key factors contributing to favorable outcomes. However, previous studies have primarily focused on estimating conditional effects, and to the best of our knowledge, there are no reports estimating the average causal effect within the population when surgical volume is treated as an intervention variable. In this study, we will conduct an epidemiological study using the DPC (Diagnosis Procedure Combination) database-a nationwide database in Japan-and a methodology called "Target Trial Emulation", which simulates an ideal randomized controlled trial (target trial). The objective of this study is to estimate the causal effect between intervention strategies that altering the number of brain tumor surgeries performed at medical institutions and short-term postoperative outcomes for brain tumors by clearly defining ideal trial conditions and emulating them using observational study data.
Basic objectives2
Others
Basic objectives -Others
In-hospital mortality, mortality within 30 days of surgery and unscheduled readmission within 30 days of surgery.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
In-hospital mortality
Key secondary outcomes
30-day postoperative mortality and unscheduled readmissions within 30 days of surgery
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Observation period: Patients who (1) have DPC data for hospitalizations between April 2018 and March 2023, based on the date of discharge; (2) underwent specific surgeries for brain tumors (defined by seven types of K-codes: K1691, K1692, K154-3, K169-2, K 169-3, K 171-22, K171-21) during the observation period; (3) classified under ICD-10 codes Cxx and Dxx, which indicate neoplasms (tumors); (4) were all ages.
Key exclusion criteria
None. (We will cope with multiple imputation for missing value of covariates in analysis.)
Target sample size
27000
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Goto |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Public Health
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2610
agoto@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Chihiro |
| Middle name | |
| Last name | Oka |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Public Health
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2610
Homepage URL
oka.chi.ld@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) Grant-in-Aid for JSPS Research Fellows (JSPS Research Fellow)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Children's Cancer Association of Japan
IRB Contact (For public release)
Organization
The Ethics Committee of the School of Medicine, Yokohama City University
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel
045-370-7627
rinri@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The objective of this study is to conduct a retrospective observational study using DPC (Diagnosis-Procedure Combination). The study population consists of patients who underwent specific brain tumor surgeries between April 1, 2018, and March 31, 2023.
"Exposure" refers to the number of surgeries performed in the previous year at the facility where each patient underwent surgery. The study population and exposure are defined by age and the K code for the surgical procedure. Within each patient cohort, participants are classified according to the following intervention strategies:
Interventions involving surgery at hospitals with 1) zero percentile or higher, 2) 25th percentile or higher, or 3) 50th percentile or higher, or 4) 75th percentile or higher in the number of surgeries performed.
The primary outcome is in-hospital death after surgery, and we will estimate changes in the cumulative incidence rate.
Management information
Registered date
| 2026 | Year | 06 | Month | 04 | Day |
Last modified on
| 2026 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070722
