UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011783 |
|---|---|
| Receipt number | R000013721 |
| Scientific Title | The effectiveness and safety of endoscopic submucosal dissection using an overtube with check valve for early gastric cancer: multicenter study |
| Date of disclosure of the study information | 2013/09/18 |
| Last modified on | 2013/09/17 18:30:54 |
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Basic information
Public title
The effectiveness and safety of endoscopic submucosal dissection using an overtube with check valve for early gastric cancer: multicenter study
Acronym
The effectiveness and safety of endoscopic submucosal dissection using an overtube with check valve for early gastric cancer: multicenter study
Scientific Title
The effectiveness and safety of endoscopic submucosal dissection using an overtube with check valve for early gastric cancer: multicenter study
Scientific Title:Acronym
The effectiveness and safety of endoscopic submucosal dissection using an overtube with check valve for early gastric cancer: multicenter study
Region
| Japan |
Condition
Condition
Early Gastric Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to assess the efficacy of the overtube with the check valve (leakcutter) for collapse of stomach during the ESD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
En bloc resection rate
Key secondary outcomes
Curative resection rate
Procedure time: time from injection into
submucosa to completion
of dissection
Difficulty of procedure: measured by VAS
The rate of adverse events and complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
from January 30 2013 to March 31 2015
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
The cases with hiatus hernia (Makuuchi Classification A or B) among the cases of indication of ESD for early gastric neoplasia.
Key exclusion criteria
1, Patients with perforamance status of 4
2, Patients with prior gastrectomy
3, Patients with severe comorbidity.
4, Those patients who are not able to
understand written information.
5, Unsuitable patients for the entry
judged by investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Sato |
Organization
Toho University Ohashi Medical Center
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
2-17-6 Ohashi Mekuro-ku Tokyo, 153-8515
TEL
03-3468-1251
kou08@oha.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Sato |
Organization
Toho University Ohashi Medical Center
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
2-17-6 Ohashi Mekuro-ku Tokyo, 153-8515
TEL
03-3468-1251
Homepage URL
kou08@oha.toho-u.ac.jp
Sponsor or person
Institute
Toho University Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization Osaka National Hospital
Syonai Amarume Hospital
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
東邦大学医療センター大橋病院 （東京都）Toho University Ohashi Medical Center
国立病院機構大阪医療センター （大阪府）National Hospital Organization Osaka National Hospital
庄内余目病院 （山形県）Syonai Amarume Hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 18 | 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
| 2013 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 18 | 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
| 2013 | Year | 09 | Month | 17 | Day |
Last modified on
| 2013 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013721
