UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063408 |
|---|---|
| Receipt number | R000072571 |
| Scientific Title | Association Between Intestinal Ultrasound Using Superb Microvascular Imaging and Endoscopic Remission in Patients With Clinically Quiescent Ulcerative Colitis: A Single-Center Prospective Observational Study |
| Date of disclosure of the study information | 2026/10/31 |
| Last modified on | 2026/10/25 12:01:21 |
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Basic information
Public title
Association Between Intestinal Ultrasound Using Superb Microvascular Imaging and Endoscopic Remission in Patients With Clinically Quiescent Ulcerative Colitis
Acronym
SMI-UC Study
Scientific Title
Association Between Intestinal Ultrasound Using Superb Microvascular Imaging and Endoscopic Remission in Patients With Clinically Quiescent Ulcerative Colitis: A Single-Center Prospective Observational Study
Scientific Title:Acronym
SMI-UC Study
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the ability of Superb Microvascular Imaging (SMI)-based microvascular flow assessment using intestinal ultrasound to discriminate endoscopic remission in patients with clinically quiescent ulcerative colitis. Specifically, the areas under the receiver operating characteristic curves of the SMI flow score and conventional color Doppler flow score will be compared to assess the utility of SMI.
Basic objectives2
Others
Basic objectives -Others
Assessment of diagnostic performance for identifying endoscopic remission
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the diagnostic performance of SMI and color Doppler flow scores for identifying endoscopic remission.
Assessment timing: Intestinal ultrasound will be performed within one month after colonoscopy.
Key secondary outcomes
1. Diagnostic performance of bowel wall thickness, IBUS-SAS, and SMI-IBUS-SAS for identifying endoscopic remission.
2. Correlations between intestinal ultrasound parameters (color Doppler flow score, SMI flow score, bowel wall thickness, IBUS-SAS, and SMI-IBUS-SAS) and endoscopic activity scores.
3. Interobserver agreement for color Doppler flow scores and SMI flow scores.
Assessment timing: Intestinal ultrasound will be performed within one month after colonoscopy.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with ulcerative colitis
2. Patients aged 18 years or older
3. Patients with left-sided or extensive ulcerative colitis
4. Patients in clinical remission (PRO2 of 1 or less and rectal bleeding subscore of 0)
5. Patients scheduled for colonoscopy to assess endoscopic disease activity
6. Patients who have provided written informed consent to participate in the study
Key exclusion criteria
1. Pregnant patients
2. Patients with a history of colectomy
3. Patients in whom intestinal ultrasound assessment is considered difficult due to a distance of 3 cm or more between the abdominal wall and the bowel wall
4. Patients with ulcerative proctitis
5. Patients who do not meet the criteria for clinical remission at the follow-up visit
6. Patients considered unsuitable for participation by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Madarame |
Organization
Tokyo Medical University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
1600023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
0333426111
madarame@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Madarame |
Organization
Tokyo Medical University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
1600023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
0333426111
Homepage URL
madarame@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Akira Madarame
Funding Source
Organization
Tokyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Medical Ethics Committee
Address
6-1-1 shinjuku, Shinjuku-ku, Tokyo
Tel
0333426111
adm_irb@tokyo-med.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
東京医科大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 31 | 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 | 10 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational study involving 60 patients with ulcerative colitis in clinical remission. One intestinal ultrasound examination will be performed for research purposes within one month after colonoscopy scheduled as part of routine clinical care. B-mode ultrasound, conventional color Doppler, and Superb Microvascular Imaging (SMI) will be used to assess bowel wall characteristics and blood flow, and their associations with endoscopic activity scores will be evaluated. The primary outcome is the comparison of the ability of SMI and color Doppler flow scores to identify endoscopic remission. No therapeutic intervention or modification of routine clinical care will be performed.
Management information
Registered date
| 2026 | Year | 10 | Month | 25 | Day |
Last modified on
| 2026 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072571
