UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006754 |
|---|---|
| Receipt number | R000007986 |
| Scientific Title | Comparative study of tunneling bloc biopsy versus EUS-fine needle aspiration for GI subepithelial tumor (a prospective comparative study in the same case) |
| Date of disclosure of the study information | 2011/11/23 |
| Last modified on | 2016/11/24 12:59:35 |
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Basic information
Public title
Comparative study of tunneling bloc biopsy versus EUS-fine needle aspiration for GI subepithelial tumor
(a prospective comparative study in the same case)
Acronym
Tunneling bloc biopsy for GI subepithelial tumor
Scientific Title
Comparative study of tunneling bloc biopsy versus EUS-fine needle aspiration for GI subepithelial tumor
(a prospective comparative study in the same case)
Scientific Title:Acronym
Tunneling bloc biopsy for GI subepithelial tumor
Region
| Japan |
Condition
Condition
Gastrointestinal submucosal tumor
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the usefulness and safety of a new biopsy method for SMT
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immunohistological diagnostic ratio
complication rate
Key secondary outcomes
technical success rate
procedure time
biopsy frequency
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
tunneling bloc biopsy
Interventions/Control_2
EUS-FNAB
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
Cases of tumor protruding in submucosa by EUS and CT imagings
Key exclusion criteria
extraluminal tumor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Kobara |
Organization
Kagawa Medical University
Division name
Department of Gastroenterology and Neurology
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793 Japan.
TEL
087-891-2156
kobara@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Kobara |
Organization
Kagawa Medical University
Division name
Department of Gastroenterology and Neurology
Zip code
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
087-891-2156
Homepage URL
kobara@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kagawa Medical University
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
| 2011 | Year | 11 | Month | 23 | 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
The study was a non-randomized, prospective comparative study with crossover design in patients with endoluminal gastric subepithelial lesions (SELs). Forty-three patients, including 29 cases with lesions <2 cm were enrolled. A crossover design with two intervention phases (Group A: EUS-guided fine needle aspiration (FNA) followed by STB for 23 SELs, Group B: STB followed by FNA for 20 SELs) was implemented. The primary outcome was the diagnostic yield (DY). Secondary outcomes were technical success rate, procedure time, complication rate, and sample quality.
Results: The DY of STB was significantly higher than that of FNA (100% vs. 34.8%) in group A, including 100% in overall STB. The technical success rate of STB was significantly higher than that of FNA (100% vs. 56.5%), whereas the median procedure time of STB was significantly longer than that of FNA (37 minutes vs. 18 minutes). The median specimen area of STB samples was markedly larger than that of FNA samples (5.54 mm2 vs. 0.69 mm2). No complications occurred in either method.
Conclusions: STB had significantly superior diagnostic ability and a more adequate sample quality than FNA for endoluminal gastric SELs, indicating the suitability of STB for small SELs.
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
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 20 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 25 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 21 | Day |
Last modified on
| 2016 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007986
