UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015364 |
|---|---|
| Receipt number | R000017797 |
| Scientific Title | EUS-guided cutting biopsy using forward-viewing echoendoscope in the diagnosis of gastrointestinal subepithelial tumors |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2017/10/16 09:26:18 |
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Basic information
Public title
EUS-guided cutting biopsy using forward-viewing echoendoscope in the diagnosis of gastrointestinal subepithelial tumors
Acronym
Cutting biopsy using forward-viewing echoendoscope
Scientific Title
EUS-guided cutting biopsy using forward-viewing echoendoscope in the diagnosis of gastrointestinal subepithelial tumors
Scientific Title:Acronym
Cutting biopsy using forward-viewing echoendoscope
Region
| Japan |
Condition
Condition
gastrointestinal subepithelial tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate feasibility and safety of the cutting biopsy using forward-viewing echoendoscope
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
diagnostic yield
Key secondary outcomes
procedure time, sample size of spicemen, complication
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
Mucosa and submucosa are cut using needle knife or hot biopsy. Biopsy is taken with biopsy forceps using forward-viewing echoendoscope. Wound is closed using endoclip.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
gastrointestinal subepithelial lesion, more than 1.5cm in tumor size
Key exclusion criteria
Cases with severe complications and lack of patients consent are excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidemi Goto |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65, Tsuruma-cho, Showa-ku, Nagoya
TEL
052-744-2172
hgoto@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ippei Matsuzaki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65, Tsuruma-cho, Showa-ku, Nagoya
TEL
052-744-2172
Homepage URL
imatsu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | 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
| 2014 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | 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 | 10 | Month | 07 | Day |
Last modified on
| 2017 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017797
