UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020198 |
|---|---|
| Receipt number | R000023328 |
| Scientific Title | Prospective randomized controlled study about the effectiveness of the continuous insufflation method for the observation of cervical esophagus. |
| Date of disclosure of the study information | 2015/12/15 |
| Last modified on | 2017/07/09 09:40:13 |
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Basic information
Public title
Prospective randomized controlled study about the effectiveness of the continuous insufflation method for the observation of cervical esophagus.
Acronym
Continuous insufflation method study
Scientific Title
Prospective randomized controlled study about the effectiveness of the continuous insufflation method for the observation of cervical esophagus.
Scientific Title:Acronym
Continuous insufflation method study
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the continuous insufflation method for the observation of cervical esophagus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Observation rate of palisade vessels in cervical esophagus (Continuous insufflation group vs control group)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Continuous insufflation during the observation of cervical esophagus
Interventions/Control_2
Conventional observation
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who undergo esophagogastroduodenoscopy
Key exclusion criteria
1.The patients who rejected informed consent
2.The patients who have a history of therapy for cervical esophagus cancer.
3.The patients who have stenosis of cervical esophagus
4.The patients who can not hold their breath
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaaki Kishino |
Organization
Nara City Hospital
Division name
Gastroenterology
Zip code
Address
1-50-1 Higashikideracho, Nara, Nara, Japan.
TEL
0742-24-1251
kishinotakaaki@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Kishino |
Organization
Nara City Hospital
Division name
Gastroenterology
Zip code
Address
1-50-1 Higashikideracho, Nara, Nara, Japan.
TEL
0742-24-1251
Homepage URL
kishinotakaaki@hotmail.co.jp
Sponsor or person
Institute
nara city hospital
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
Address
Tel
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 | 12 | Month | 15 | 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
Observation rate of palisade vessels in cervical esophagus
Continuous insufflation group 67%
Control group 22%
risk ratio 3.05(2.1-4.5)
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
| 2015 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 15 | Day |
Last modified on
| 2017 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023328
