UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057983 |
|---|---|
| Receipt number | R000066210 |
| Scientific Title | Clinical impact of combination of lesion-border findings and pit patterns for identifying invasive versus non-invasive neoplastic lesions in ulcerative colitis |
| Date of disclosure of the study information | 2025/05/29 |
| Last modified on | 2025/05/27 15:46:18 |
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Basic information
Public title
Clinical impact of combination of lesion-border findings and chromoendoscopic magnification for colorectal lesions in ulcerative colitis
Acronym
Lesion-border findings in ulcerative colitis
Scientific Title
Clinical impact of combination of lesion-border findings and pit patterns for identifying invasive versus non-invasive neoplastic lesions in ulcerative colitis
Scientific Title:Acronym
Lesion-border findings in ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients with ulcerative colitis have a high incidence of colorectal neoplasia. Pit pattern is useful for assessing the depth of colorectal neoplasia in the general population; however, its application in UC-associated neoplasia is limited. Inaccurate preoperative depth diagnosis may lead to positive resection margins and perforation. We aimed to evaluate the usefulness of combining lesion-border findings with pit pattern to improve the identification of intramucosal lesions suitable for endoscopic resection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The sensitivity, specificity, and accuracy of pit pattern for identifying intramucosal lesions .
Key secondary outcomes
The inter- and intra-observer reproducibility among the three endoscopists (one expert and two non-experts).
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
Eligible patients were diagnosed with UC and underwent endoscopic or surgical resection of neoplastic lesions between April 2001 and December 2024.
Key exclusion criteria
Individuals who did not consent to participate in the study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | YURIE |
| Middle name | |
| Last name | KAWABATA |
Organization
Showa Medical University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1 Chiagsakichuo,Tsuzuki, Yokohama, Kanagawa
TEL
045-949-7000
chabee0203yk@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | YURIE |
| Middle name | |
| Last name | KAWABATA |
Organization
Showa Medical University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1 Chiagsakichuo,Tsuzuki, Yokohama, Kanagawa
TEL
045-949-7000
Homepage URL
chabee0203yk@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Takeda Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Society for the Promotion of Science
IRB Contact (For public release)
Organization
Showa Medical University
Address
1-5-8 Hatanodai,Shinagawa,Tokyo,Japan
Tel
03-3784-8000
showa-u@esct.bvits.com
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
| 2025 | Year | 05 | Month | 29 | 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
108
Results
The sensitivity and accuracy of pit pattern for differentiating intramucosal lesions were significantly higher for lesions with a distinct border.The diagnostic abilities of indistinct lesion-border to differentiate between non-conventional and conventional histologic patterns were 90.0% for sensitivity,96.6% for specificity and 94.9% for accuracy.The inter-observer reproducibilities were 0.60 or more.The intra-observer reproducibilities were>0.60.
Results date posted
| 2025 | Year | 05 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We analyzed 158 lesions from 108 patients with UC.The median patient age was 57 years(interquartile range,70% of the participants were male and the median disease duration was 15 years.
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This single-center, retrospective study analyzed 158 colorectal lesions in patients with UC. Lesions were resected endoscopically or surgically following magnifying chromoendoscopy observation and borders were defined as distinct or indistinct. The predictive value of pit patterns for identifying intramucosal lesions was evaluated.
Management information
Registered date
| 2025 | Year | 05 | Month | 27 | Day |
Last modified on
| 2025 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066210
