UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020831 |
|---|---|
| Receipt number | R000024047 |
| Scientific Title | A prospective study of endoscopic diagnosis through the submucosal tunnel for gastrointestinal submucosal tumors |
| Date of disclosure of the study information | 2016/02/03 |
| Last modified on | 2023/02/06 10:29:27 |
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Basic information
Public title
A prospective study of endoscopic diagnosis through the submucosal tunnel for gastrointestinal submucosal tumors
Acronym
Endoscopically visualized imaging of gastrointestinal submucosal tumor
Scientific Title
A prospective study of endoscopic diagnosis through the submucosal tunnel for gastrointestinal submucosal tumors
Scientific Title:Acronym
Endoscopically visualized imaging of gastrointestinal submucosal tumor
Region
| Japan |
Condition
Condition
gastrointestinal submucosal tumors including subepithelial tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore if endoscopically visualized imagings via submucosal tunnel produce a novel classification of GI submucosal tumors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concordant rate between endoscopic visual diagnosis according to our proposed classification of submucosal tumors and the histological final diagnosis
Key secondary outcomes
1.The rate of endoscopic visualization via submucosal tunnel of submucosal tumors
2.The validity of the classification of submucosal tumors
3.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
| Maneuver |
Interventions/Control_1
Submucosal tunneling biopsy (STB), which offers sufficient specimens of submucosal tumor (SMT) without contamination under direct vision
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
tumors which appear in the submucosa
Key exclusion criteria
tumors which do not appear in the submucosa or extraluminally growing tumors by endosonography and computed tomography
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Kobara |
Organization
Faculty of Medicine, Kagawa University
Division name
Gastroenterology and Neurology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
0878912156
kobara.hideki@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kobara |
Organization
Faculty of Medicine, Kagawa University
Division name
Investigator
Zip code
761-0793
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
+81878985111
Homepage URL
kobara@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Gastroenterology and Neurology, Faculty of Medicine, Kagawa 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
e Clinical Ethics Committee of Kagawa University Hospital
Address
Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
Tel
0878912156
chosa@med.kagawa-u.ac.jp
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
| 2016 | Year | 02 | Month | 03 | 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
40
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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 01 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024047
