UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041487 |
|---|---|
| Receipt number | R000047367 |
| Scientific Title | Clinical impact of the under water method for colorectal endoscopic submucosal dissection by non-expert |
| Date of disclosure of the study information | 2020/08/20 |
| Last modified on | 2025/02/25 19:00:46 |
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Basic information
Public title
Clinical impact of the under water method for colorectal endoscopic submucosal dissection by non-expert
Acronym
Clinical impact of the under water method for colorectal endoscopic submucosal dissection by non-expert
Scientific Title
Clinical impact of the under water method for colorectal endoscopic submucosal dissection by non-expert
Scientific Title:Acronym
Clinical impact of the under water method for colorectal endoscopic submucosal dissection by non-expert
Region
| Japan |
Condition
Condition
colorectal tumor
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine whether the under water method contributes to the safe procedure of colorectal ESD by non-expert.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of under water ESD by non-expert
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
ESD for colorectal tumors using conventional methods.
Interventions/Control_2
ESD for colorectal tumors using the under water method.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with colorectal tumors that are considered to be capable of en bloc resection and who are scheduled to undergo ESD will be included in the study.
Key exclusion criteria
1) Under 20 years old
2) Pregnant women
3) Persons with a serious underlying disease
4) Patients taking antithrombotic drugs
5) Local recurrence
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Irisawa |
Organization
Dokkyo Medical University
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Tochigi 321-0293, Japan.
TEL
0282-86-1111
irisawa@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Kanamori |
Organization
Dokkyo Medical University
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Tochigi 321-0293, Japan.
TEL
0282-86-1111
Homepage URL
k-akira@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Committee of Dokkyo Medical University Hospital
Address
880, Kitakobayashi, Mibu, Tochigi 321-0293, Japan.
Tel
0282-86-1111
r-kenkyu@dokkyomed.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
| 2020 | Year | 08 | Month | 20 | 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
| 2019 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 02 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 20 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047367
