UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018039 |
|---|---|
| Receipt number | R000020897 |
| Scientific Title | Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD |
| Date of disclosure of the study information | 2015/06/23 |
| Last modified on | 2021/07/17 14:30:12 |
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Basic information
Public title
Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD
Acronym
Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD
Scientific Title
Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD
Scientific Title:Acronym
Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD
Region
| Japan |
Condition
Condition
early gastric cancer, early colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of the Dual knife with a water-jet function for the gastrointestinal ESD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome is to verify the feasibility of mucosal elevation.
Key secondary outcomes
The secondary outcomes include the procedure time, the en bloc resection rate, the number of endoscopic device changes (endoscopic injection needle, different device), the adverse event rate such as post-operative bleeding and perforation.
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We undergo the ESD by the use of the Dual knife with a water-jet function.
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
1)Patients who are diagnosed as early gastric cancer and early colorectal cancer and are considered as the indication of ESD treatment.
2)Provided with written informed conscent.
Key exclusion criteria
1)Patients whose lesions are found to be outside the guideline or expanded criteria for ESD.
2)Severe fibrosis.
3)Patients with hematological abnormality.
4)Severe liver dysfunction, Severe renal dysfunction, Severe heart dysfunction.
5)Patients who are pregnant or lactation.
6)Patients without written informed consent.
7)Lesions which are thought to be difficult to resect by ESD because of unstable positioning of endoscope.
8)Patients who are disqualified for the study by physicians
9)Refusal of the trial entry.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naohisa |
| Middle name | |
| Last name | Yahagi |
Organization
Keio University, School of Medicine
Division name
Cancer Center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
yahagi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tadateru |
| Middle name | |
| Last name | Maehata |
Organization
Keio University, School of Medicine
Division name
Cancer Center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
t2maehata@marianna-u.ac.jp
Sponsor or person
Institute
Keio University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University, School of Medicine
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
Keio University
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2015 | Year | 06 | 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
All the lesions were successfully treated by mucosal elevation. The median resected specimen size in stomach and colorectum lesions were 37.3mm and 34.0 mm respectively. The mean procedure time in stomach and colorectum lesions were 36 min and 32.3 min respectively. The en bloc resection rates were 100% in both lesions. The median number of endoscopic device changes in stomach and colorectum lesions were three times and four times respectively. No severe adverse events were observed in both lesions.
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
| 2014 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 23 | Day |
Last modified on
| 2021 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020897
