UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008305 |
|---|---|
| Receipt number | R000009780 |
| Scientific Title | Endoscopic ultrasound guided biopsy using Echotip ProCore needle for gastric SET |
| Date of disclosure of the study information | 2012/06/29 |
| Last modified on | 2015/07/22 19:05:59 |
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Basic information
Public title
Endoscopic ultrasound guided biopsy using Echotip ProCore needle for gastric SET
Acronym
EUS guided biopsy using Echotip ProCore needle for gastric SET
Scientific Title
Endoscopic ultrasound guided biopsy using Echotip ProCore needle for gastric SET
Scientific Title:Acronym
EUS guided biopsy using Echotip ProCore needle for gastric SET
Region
| Asia(except Japan) |
Condition
Condition
subepithelial lesion of upper gastrointestinal tract
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparision of diagnostic yield for SET of upper GI tract between EUS-FNA and EUS-needle biopy using ProCore needle
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diganostic yield of EUS-FNA and EUS needle biopsy for cytology and immunohistochemical stain
Key secondary outcomes
Proceduresrelated complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
EUS guided needle biopsy using ProCore needle
Interventions/Control_2
EUS guided FNA
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Gastric GI SET more than 1.5cm
Key exclusion criteria
Bleeding tendency
Upper GI SET less than 1.5cm
Pregnant women
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Su Jin Hong |
Organization
Soonchunhyang University College of Medicine
Division name
Digestive Disease Center, Department of Internal Medicine
Zip code
Address
Digestive Disease Center, Soonchunhyang University Bucheon Hospital,
TEL
82-32-621-5087
sjhong@schmc.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Su Jin Hong |
Organization
Soonchunhyang University College of Medicine
Division name
Digestive Disease Center, Department of Internal Medicine
Zip code
Address
Digestive Disease Center, Soonchunhyang University Bucheon Hospital,
TEL
82-32-621-5087
Homepage URL
sjhong@schmc.ac.kr
Sponsor or person
Institute
Soonchunhyang University Research Fund
Institute
Department
Personal name
Funding Source
Organization
Soonchunhyang University Research Fund
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2012 | Year | 06 | Month | 29 | 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
EUS-FNB could decrease the number of needle passes necessary to obtain adequate cellularity and yield a greater proportion of adequate cellularity on the first pass compared to EUS-FNA. However, there was no significant difference in diagnostic yield with IHC staining between two procedures.
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
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
| 2014 | Year | 08 | Month | 28 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 29 | Day |
Last modified on
| 2015 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009780
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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