UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022843 |
|---|---|
| Receipt number | R000026327 |
| Scientific Title | Efficacy of submucosal lidocaine injection for shortening procedure time of endoscopic submucosal dissection (ESD) for the treatment of the gastric and colorectal tumor. |
| Date of disclosure of the study information | 2016/06/22 |
| Last modified on | 2023/07/14 15:58:28 |
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Basic information
Public title
Efficacy of submucosal lidocaine injection for shortening procedure time of endoscopic submucosal dissection (ESD) for the treatment of the gastric and colorectal tumor.
Acronym
Efficacy of submucosal lidocaine injection when performing ESD for the gastric and colorectal tumor.
Scientific Title
Efficacy of submucosal lidocaine injection for shortening procedure time of endoscopic submucosal dissection (ESD) for the treatment of the gastric and colorectal tumor.
Scientific Title:Acronym
Efficacy of submucosal lidocaine injection when performing ESD for the gastric and colorectal tumor.
Region
| Japan |
Condition
Condition
Gastric and colorectal tumor which will be removed by ESD.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In order to evaluate 1) procedure time, 2) the complications of operation and lidocaine, 3) amounts of peristalsis depressants used in patients who is performed ESD for gastric and colorectal tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The procedure time of ESD between lidocaine injected group and control group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Submucosal injection of lidocaine.
Interventions/Control_2
Submucosal injection of saline.
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
| 17 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with gastric or colorectal tumor which will be removed by ESD.
Key exclusion criteria
1. Severe cardiac disease.
2. Severe kidney disease.
3. Severe infectious disease.
4, Severe diabetes.
5. Severe psychiatric disease.
6. Severe dehydration and nutritional disorder.
7. Patients with bleeding disorders.
8. Patients with severe complications who were determined to be inappropriate to carry out the study.
9. History of hypersensitivity to lidocaine.
10. Patients with tumors which cannot be removed by ESD.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Mikihiro |
| Middle name | |
| Last name | Fujiya |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterology and Hematology/Oncology, Department of Medicine
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, Japan
TEL
0166-68-2462
fujiya2008@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Masami |
| Middle name | |
| Last name | Ijiri |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterology and Hematology/Oncology, Department of Medicine
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, Japan
TEL
0166-68-2462
Homepage URL
m-ijiri@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, Japan
Tel
0166-68-2187
rs-kk.g@asahikawa-med.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 | 06 | Month | 22 | 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
225
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 12 | 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 | 06 | Month | 22 | Day |
Last modified on
| 2023 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026327
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| Registered date | File name |
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| Registered date | File name |
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