UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006441 |
|---|---|
| Receipt number | R000007640 |
| Scientific Title | Double blind randomized controlled trial to assess mediastinal emphysema after esophageal endoscopic submucosal dissection with insufflation of carbon dioxide |
| Date of disclosure of the study information | 2012/03/31 |
| Last modified on | 2016/01/03 17:25:51 |
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Basic information
Public title
Double blind randomized controlled trial to assess mediastinal emphysema after esophageal endoscopic submucosal dissection with insufflation of carbon dioxide
Acronym
Double blind randomized controlled trial to assess mediastinal emphysema after esophageal endoscopic submucosal dissection with insufflation of carbon dioxide
Scientific Title
Double blind randomized controlled trial to assess mediastinal emphysema after esophageal endoscopic submucosal dissection with insufflation of carbon dioxide
Scientific Title:Acronym
Double blind randomized controlled trial to assess mediastinal emphysema after esophageal endoscopic submucosal dissection with insufflation of carbon dioxide
Region
| Japan |
Condition
Condition
superficial esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence and severity of post-ESD ME in patients receiving CO2 insufflation versus standard air insufflation during esophageal ESD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence and severity of post-ESD ME in patients receiving CO2 insufflation
Key secondary outcomes
clinical course, treatment results, safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
insufflation of CO2 or Air
Interventions/Control_2
Multi-detector row computed tomography (MDCT) was carried out immediately after ESD. A conventional chest X-ray was taken the next day.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who undergo esophageal ESD
Key exclusion criteria
inability to provide informed consent, severe chronic obstructive pulmonary disease, and synchronous multiple lesions.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yuki maeda |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL
022-252-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology, Sendai City Medical Center
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
仙台市医療センター仙台オープン病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 31 | 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
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 29 | Day |
Last modified on
| 2016 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007640
