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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-jRCTs041180035 |
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Date of registration:
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31/01/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dual center study of pCLE for UCAN
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Scientific title:
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Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia |
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Date of first enrolment:
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15/12/2017 |
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Target sample size:
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30 |
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Recruitment status: |
Complete |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCTs041180035 |
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Study type:
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Interventional |
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Study design:
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non-randomized controlled trial, open(masking not used), uncontrolled control, single assignment, diagnostic purpose
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Phase:
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N/A
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Contacts
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Name:
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Naoki
Ohmiya |
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Address:
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1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi
470-1192
Aichi
Japan |
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Telephone:
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+81-562-93-9240 |
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Email:
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shokakan@fujita-hu.ac.jp |
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Affiliation:
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Fujita Health University Hospital |
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Name:
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Masashi
Kondo |
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Address:
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1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi
470-1192
Aichi
Japan |
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Telephone:
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+81-562-93-9362 |
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Email:
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mkond@fujita-hu.ac.jp |
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Affiliation:
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Fujita Health University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Suspected UCAN
Exclusion criteria: 1. Patients with prevous history of allergy to fluorescein
2. Patients in too bad condition to undergo endoscopy.
3. Patients with severe diabetes
4. Patients with severe cardiac disease
5. Patients with severe cerebrovascular disease
6. Patients with cirrhosis
7. Patients with pheochomocytoma
8. Patients with bleeding tendencies
9. Pregnant or possible pregnant women
10. Patients with contraindication of endoscopy
Age minimum:
>= 20age old
Age maximum:
< 80age old
Gender:
Both
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Health Condition(s) or Problem(s) studied
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suspected ulcerative colitis-associated neoplasia
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Intervention(s)
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pCLE after intravenous administration of fluorescein
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Primary Outcome(s)
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Diagnostic yields of pCLE, magnifying narrow band imaging (NBI), and magnifying choromoendoscopy for suspected UCAN, compared with pathological diagnosis.
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Secondary Outcome(s)
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Adverse events of pCLE and fluorescein
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Source(s) of Monetary Support
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Ethics review
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Status: Approval
Approval date:
Contact:
crb-f@fujita-hu.ac.jp
Fujita Health University Certified Review Board
+81-562-93-2865
crb-f@fujita-hu.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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31/05/2022 |
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Date Completed:
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31/01/2022 |
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URL:
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