UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038692 |
|---|---|
| Receipt number | R000044102 |
| Scientific Title | Study on usefulness of jelly injection in hemostasis during endoscopic submucosa dissection |
| Date of disclosure of the study information | 2019/12/24 |
| Last modified on | 2020/05/27 09:04:44 |
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Basic information
Public title
Study on usefulness of jelly injection in hemostasis during endoscopic submucosa dissection
Acronym
JH trial
Scientific Title
Study on usefulness of jelly injection in hemostasis during endoscopic submucosa dissection
Scientific Title:Acronym
JH trial
Region
| Japan |
Condition
Condition
gastric cancer,esophageal cancer,colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and effectiveness of transendoscopic injection of oral rehydration jelly (OS-1 jelly) during hemostasis during endoscopic submucosal dissection to improve visual field.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In Phase I, OS-1 jelly was used to improve the field of view and evaluate safety when hemostasis occurred.
In Phase II, the time taken to identify the bleeding site in the normal group and jelly combination 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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
For bleeding during endoscopic submucosal dissection, an oral rehydration jelly is injected to identify the bleeding site. There is no upper limit to the number and amount of jelly injections.
Interventions/Control_2
For bleeding during endoscopic submucosal dissection, an oral rehydration jelly is injected to identify the bleeding site. There is no upper limit to the number and amount of jelly injections.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who are scheduled for endoscopic submucosal dissection of the esophagus, stomach, and large intestine.
2) Age at the time of obtaining consent is 20 years old or older and less than 80 years old.
3) Informed consent has been obtained from the patient regarding participation in this study.
Key exclusion criteria
1) Patients who are likely to have perforated or have perforated during endoscopic submucosal dissection.
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Takatori |
Organization
Kanazawa University Hospital
Division name
Department of Gastroenterology
Zip code
9208641
Address
13-1,Takara-machi,Kanazawa
TEL
0762652235
hajimetakatori@gmail.com
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Takatori |
Organization
Kanazawa University Hospital
Division name
Department of Gastroenterology
Zip code
9208641
Address
13-1,Takara-machi,Kanazawa
TEL
0762652235
Homepage URL
hajimetakatori@gmail.com
Sponsor or person
Institute
Department of Gastroenterology, Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Kanazawa University Hospital
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
iCREK
Address
13-1,Takara-machi,Kanazawa
Tel
076-265-2049
crc.irb-knz@esct.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
| 2019 | Year | 12 | Month | 24 | 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 | 11 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 11 | Month | 26 | Day |
Last modified on
| 2020 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044102
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
