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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006754
Receipt No. 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

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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
Email 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
Email kobara@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007986

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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