UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009759 |
|---|---|
| Receipt number | R000011396 |
| Scientific Title | Pathological evaluation of the intestinal tract with confocal laser endomicroscopy |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2018/07/17 11:39:24 |
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Basic information
Public title
Pathological evaluation of the intestinal tract with confocal laser endomicroscopy
Acronym
Pathological evaluation of the intestinal tract with confocal laser endomicroscopy
Scientific Title
Pathological evaluation of the intestinal tract with confocal laser endomicroscopy
Scientific Title:Acronym
Pathological evaluation of the intestinal tract with confocal laser endomicroscopy
Region
| Japan |
Condition
Condition
GI epithelial lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Confocal laser endomicroscopy (CLE) is a newly established endoscopic method providing in vivo histology at a subcellular resolution during ongoing endoscopy.
In this study, we will evaluate the safety of the technology and also conduct the CLE analysis of GI epithelial mucosal diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The procedural success rate of the visualization of the structure.
Key secondary outcomes
1) Comparing CLE findings with normal endoscopic findings, magnifying-endoscopic findings and pathological findings
2) Differential diagnosis
3) Image quality assessment. The evaluation criteria are divided into three(poor, almost invisible tissue structure; mild, visible tissue structure with too dark vision; good, clearly visible tissue structure).
4) Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Transvenous administration of 10% solution or topical application of 0.1% fluorescein solution will be performed for tissue visualization with CLE. Then, the studied sites will be biopsied and the specimens will be histologically evaluated.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with suspected digestive disease such as a gastric carcinoma, gastric adenoma, colon carcinoma, colon adenoma.
Key exclusion criteria
1) Patients not indicated for normal endoscopy
2) History of allergy to fluorescein dye
3) Subjects with a severe comorbidity such as a diabetic disease, cardiovascular, neurologic dysfunction, cirrhosis of the liver, pheochromocytoma and pregnancy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuki Sumiyama |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
Address
3-25-8, Nishi-Shinbashi, Minato-ku Tokyo
TEL
03-3433-1111(ext.3181)
kaz_sum@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakuni Kobayashi |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
Address
3-25-8, Nishi-Shinbashi, Minato-ku Tokyo
TEL
03-3433-1111(ext.3181)
Homepage URL
masakuni@jikei.ac.jp
Sponsor or person
Institute
Department of Endoscopy
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Address
Tel
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
東京慈恵会医科大学附属病院 内視鏡科
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | 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
| 2013 | Year | 01 | Month | 11 | Day |
Last modified on
| 2018 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011396
