UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000047855
Receipt number	R000054556
Scientific Title	Construction of a spleen volume database by three-dimensional measurement using CT images: Search for factors defining normal spleen volume and redefinition of splenomegaly.
Date of disclosure of the study information	2025/04/01
Last modified on	2026/05/28 12:00:25

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Basic information

Public title

Construction of a spleen volume database by three-dimensional measurement using CT images: Search for factors defining normal spleen volume and redefinition of splenomegaly.

Acronym

Construction of a spleen volume database by three-dimensional measurement using CT images: Search for factors defining normal spleen volume and redefinition of splenomegaly.

Scientific Title

Construction of a spleen volume database by three-dimensional measurement using CT images: Search for factors defining normal spleen volume and redefinition of splenomegaly.

Scientific Title:Acronym

Construction of a spleen volume database by three-dimensional measurement using CT images: Search for factors defining normal spleen volume and redefinition of splenomegaly.

Region

Japan

Condition

Patients who underwent CT including abdomen at Iwate Medical University from April 1, 2011 to April 1, 2022

Classification by specialty

Medicine in general Radiology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To determine the normal distribution of splenic volume in healthy adults using automated organ segmentation techniques on abdominal CT images. Based on the normal distribution of splenic volume, we aimed to establish an objective diagnostic definition of splenomegaly by setting a threshold for splenomegaly.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

To clarify the normal distribution of spleen volume in a healthy adult population, we will accumulate spleen volume data using automated organ segmentation technology for a set patient population and examine factors that determine patient-specific spleen volume based on age, sex, height, weight, and body surface area.

Key secondary outcomes

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

20 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who have undergone CT scan including abdomen at Iwate Medical University from April 1, 2011 to April 1, 2022 and meet the following conditions.
Age is 20 years or older. Gender is not limited.
No limitation of contrast media use.

Key exclusion criteria

Examination for patients who are unconscious or in urgent and life-threatening situations
Cases with a history of contrast media side effects
Cases of suspected pregnancy
Patients with a history of the following
Underlying disease causing splenomegaly (hypersplenism, hypersplenism, congenital heart disease, liver cirrhosis, idiopathic portal hypertension, EB virus infection, acute leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, true polycythemia vera, essential thrombocythemia, myelofibrosis, hemolytic anemia, pernicious anemia, thalassemia, sarcoidosis, SLE, Felty syndrome, etc.) syndrome, amyloidosis, etc.)

Translated with www.DeepL.com/Translator (free version)

Target sample size

3000

Research contact person

Name of lead principal investigator

1st name AKIO

Middle name

Last name TAMURA

Organization

Iwate Medical University

Division name

Department of Radiology

Zip code

028-3695

Address

2-1-1, Medical University Avenue, Yahinmachi, Shiwa-gun, Iwate, Japan

TEL

019-907-7165

Email

a.akahane@gmail.com

Public contact

Name of contact person

1st name AKIO

Middle name

Last name TAMURA

Organization

Iwate Medical University

Division name

Department of Radiology

Zip code

028-3695

Address

2-1-1, Medical University Avenue, Yahinmachi, Shiwa-gun, Iwate, Japan

TEL

0196515111

Homepage URL

Email

a.akahane@gmail.com

Sponsor or person

Institute

Iwate Medical University

Institute

Department

Personal name

Funding Source

Organization

Iwate Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Iwate Medical University

Address

2-1-1, Medical University Avenue, Yahinmachi, Shiwa-gun, Iwate, Japan

Tel

0196137111

Email

a.akahane@gmail.com

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2025 Year 04 Month 01 Day

Related information

URL releasing protocol

https://link.springer.com/article/10.1186/s12876-025-04383-z

Publication of results

Partially published

Result

URL related to results and publications

https://link.springer.com/article/10.1186/s12876-025-04383-z

Number of participants that the trial has enrolled

4868

Results

Reference spleen volume values were established from CT data of 4,732 healthy Japanese adults using deep learning segmentation. The final model was predicted spleen volume (mL)=3.08+1.96xbody weight (kg), with an MAE of 33.90 mL. In 136 biopsy-confirmed chronic liver disease patients, Z-score-defined splenomegaly increased with fibrosis stage; AUC for detecting F4 cirrhosis was 0.73.

Results date posted

2026 Year 05 Month 28 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Data Set 1 included 4,732 healthy adults and was divided into a training/validation group of 3,312 participants and a test group of 1,420 participants. In the training/validation group, there were 2,064 men and 1,248 women; the mean age was 64.1+/-15.8 years, mean body weight was 60.6+/-13.7 kg, mean height was 161.2+/-9.7 cm, and mean spleen volume was 122.1+/-61.1 mL. In the test group, there were 863 men and 557 women; the mean age was 63.9+/-15.2 years, mean body weight was 60.5+/-13.8 kg, mean height was 161.3+/-9.9 cm, and mean spleen volume was 119.9+/-57.9 mL. Data Set 2 included 136 patients with chronic liver disease, consisting of 106 men and 30 women; the mean age was 69.0+/-8.2 years, mean body weight was 63.4+/-12.1 kg, mean height was 160.5+/-9.3 cm, and mean spleen volume was 207.7+/-116.3 mL. The numbers of patients with fibrosis stages F1, F2, F3, and F4 were 11, 41, 35, and 42, respectively.

Participant flow

For Data Set 1, 5,236 asymptomatic adult outpatients who underwent unenhanced abdominal CT between April 2011 and April 2022 were screened. After excluding 184 patients with missing clinical information, 157 with conditions such as cirrhosis, hepatitis, hypersplenism, splenomegaly, congenital heart disease, lymphoma, leukemia, or suspected infection, and 42 whose CT scans did not include the entire spleen, automated spleen segmentation was performed in 4,853 patients. A further 121 patients were excluded because of segmentation errors, leaving 4,732 participants for the final analysis in Data Set 1.

For Data Set 2, 140 patients with histologically confirmed chronic liver disease who underwent abdominal CT and liver biopsy within 6 months were screened. After excluding 3 patients with missing clinical information and 1 with segmentation failure, 136 patients were included in the final analysis.

Adverse events

This was a retrospective observational study using CT imaging data for spleen volume analysis. Therefore, no study intervention-related adverse events were reported.

Outcome measures

The primary outcome measures were the establishment of population-specific reference values for spleen volume in healthy Japanese adults using deep learning-based automated CT segmentation, and the development and validation of a prediction model for spleen volume based on routine clinical parameters such as body weight. Secondary outcome measures included the diagnostic utility of Z-score-defined splenomegaly for assessing liver fibrosis stage, particularly for detecting cirrhosis (F4), in patients with chronic liver disease. Specifically, the study evaluated segmentation accuracy, the mean absolute error of the prediction model, the prevalence of splenomegaly by fibrosis stage, ROC performance for F4 detection, sensitivity, and specificity.

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Preinitiation

Date of protocol fixation

2022 Year 05 Month 25 Day

Date of IRB

Anticipated trial start date

2022 Year 07 Month 01 Day

Last follow-up date

2025 Year 04 Month 01 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

To determine the normal distribution of spleen volume in healthy adults using automated organ segmentation techniques on abdominal CT images.

Management information

Registered date

2022 Year 05 Month 25 Day

Last modified on

2026 Year 05 Month 28 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054556