UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015829 |
|---|---|
| Receipt number | R000018416 |
| Scientific Title | Evaluation of esophageal motility in patient with esophageal tumor treated by esophageal endoscopic resection |
| Date of disclosure of the study information | 2014/12/03 |
| Last modified on | 2022/09/01 09:58:54 |
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Basic information
Public title
Evaluation of esophageal motility in patient with esophageal tumor treated by esophageal endoscopic resection
Acronym
effect on esophageal motility by endoscopic resection
Scientific Title
Evaluation of esophageal motility in patient with esophageal tumor treated by esophageal endoscopic resection
Scientific Title:Acronym
effect on esophageal motility by endoscopic resection
Region
| Japan |
Condition
Condition
esophageal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the esophageal motility using high-resolution manometry before and after EMR/ESD
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the esophageal motility before and after EMR/ESD
Key secondary outcomes
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 investigate HRM data which is performed before and after endoscopic resection.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have esophageal neoplastic lesion, which is possible to resect endoscopically.
In case of early cancer, the lesion is judged to resect curatively(no invasion to submucosal layer, Ly0, v0, HM0, VM0).
Patients who agreed to study participants by documents.
Key exclusion criteria
1)Rejection of Informed Consent.
2)Serious hepatic disease, heart disease, respiratory disease.
3)Difficulty of catheterization due to narrow nasal cavity, pain or Laryngopharyngeal reflux.
3)Severe allergic constitution.
4)Patients judged to be inappropriate as object in our study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Takeda |
Organization
Juntendo University faculty
of Medicine
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
t-takeda@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kenshi |
| Middle name | |
| Last name | Matsumoto |
Organization
Juntendo University hospital
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
kmatumo@juntendo.ac.jp
Sponsor or person
Institute
Department of Gastroenterology
Juntendo University faculty of Medicine
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
Juntendo University IRB
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel
0338133111
t-takeda@juntendo.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
順天堂大学附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.hindawi.com/journals/grp/2018/3735473/
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
Main results already published
Date of protocol fixation
| 2014 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 03 | 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
| 2014 | Year | 12 | Month | 03 | Day |
Last modified on
| 2022 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018416
| 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 |
