UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050512 |
|---|---|
| Receipt number | R000057461 |
| Scientific Title | The clinical trial evaluating the usefulness of Linked Color Imaging(LCI) in surveillance colonoscopy of ulcerative colitis. |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2024/09/05 19:13:52 |
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Basic information
Public title
The clinical trial evaluating the usefulness of Linked Color Imaging(LCI) in surveillance colonoscopy of ulcerative colitis.
Acronym
UC/LCI test
Scientific Title
The clinical trial evaluating the usefulness of Linked Color Imaging(LCI) in surveillance colonoscopy of ulcerative colitis.
Scientific Title:Acronym
UC/LCI test
Region
| Japan |
Condition
Condition
Ulcerqative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to demonstrate the non-inferiority of chromo-endoscopy and Linked Color Imaging (LCI) in the detection rate of ulcerative colitis associated neoplasia (UCAN) in surveillance colonoscopy for patients with ulcerative colitis. If LCI is equal to or better than chromo-endoscopy in detecting UCAN, it will reduce the time required for surveillance endoscopy, improve complexity by eliminating dye spraying, and reduce the burden on both the patient and the endoscopist during the examination. If LCI significantly improves UCAN detection, it would be a novel finding as the most effective surveillance method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
detection rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Observation after spraying indigocarmine over the entire colon during surveillance colonoscopy for patients with ulcerative colitis who have given consent.
Interventions/Control_2
Observation using LCI during surveillance colonoscopy for patients with ulcerative colitis who have given consent.
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
Patients with disease duration of more than 6 years
Patients with total or left-sided colitis
Patients who have not undergone surveillance colonoscopy in the past 6 months
Patients with a Partial Mayo score of 4 or less
Patients who understand the study and have given written consent
Key exclusion criteria
Patients with severe acute inflammation on endoscopic findings
Pregnant patients
Patients with extremely poor general condition, intestinal perforation, pancreatitis, respiratory disease, circulatory disease, acquired hemophilia, stenosis, large ulcer or tumor, or other conditions in which the risk of performing endoscopy exceeds the benefit
Patients with serious functional impairment of the heart, lungs, kidneys, or liver
Patients with bradycardia or atrioventricular block
Patients who are incapable of self-judgment
Patients with Poor and Inadequate cleanliness (Aronchick score)
Patients deemed inappropriate by the physician in charge.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamamura |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
4668560
Address
65 Tsurumai, Showa-ku, Nagoya City ,Aichi Prefecture
TEL
0527442172
tyamamu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Oiwa |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
4668560
Address
65 Tsurumai, Showa-ku, Nagoya City ,Aichi Prefecture
TEL
0527442172
Homepage URL
k-oiwa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Nagoya University Hospital Office of Medical Research and Clinical Ethics
Address
65 Tsurumai, Showa-ku, Nagoya City ,Aichi Prefecture
Tel
0527412111
ethics@med.nagoya-u.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
| 2023 | Year | 05 | Month | 01 | 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
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 06 | Day |
Last modified on
| 2024 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057461
