UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013527 |
|---|---|
| Receipt number | R000015809 |
| Scientific Title | NBI and chromoendoscopy surveillance for longstanding ulcerative colitis patients, prospective study |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2024/03/31 23:48:44 |
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Basic information
Public title
NBI and chromoendoscopy surveillance for longstanding ulcerative colitis patients, prospective study
Acronym
Navigator Study
Scientific Title
NBI and chromoendoscopy surveillance for longstanding ulcerative colitis patients, prospective study
Scientific Title:Acronym
Navigator Study
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate more effective surveillance colonoscopy in patients with ulcerative colitis based on the prospective multicenter randomized comparison study for panchromoendoscopy and pan-Narrow Band Imaging (NBI) colonoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The detection rate of panchromoendoscopy group and NBI group
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
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
surveillance colonoscopy with panchromoendoscpy
Interventions/Control_2
surveillance colonoscopy with pan-NBI observation
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
1) The patients with pancolitis or left sided colitis type of ulcerative colitis who are 20 years old and over.
2) The patients with ulcerative colitis who are 2 point of partial Mayo score and less.
Key exclusion criteria
1) The patient who was performed total or subtotal colectomy.
2) The patients who is not able to examined with surveillance colonoscopy by using EVIS LUCERA ELITE CF-HQ290I (Olympus Co., Japan).
3) The patient who is judged as inadequate by primary investigator or physician.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Watanabe |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Gastroenterology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3811
kenjiw1779@gmail.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Watanabe |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Gastroenterology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3811
Homepage URL
kenjiw1779@gmail.com
Sponsor or person
Institute
Navigator Study Group
Institute
Department
Personal name
Funding Source
Organization
The Japanese Gastroenterological Association
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
Ethical Committee of Osaka City University, Graduate School of Medicine
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
Tel
0666453435
ethics@med.osaka-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
| 2014 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015809
