UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010003 |
|---|---|
| Receipt number | R000011710 |
| Scientific Title | Randomized controlled trial to assess the efficacy of the clip with line method during esophageal endoscopic submucosal dissection |
| Date of disclosure of the study information | 2013/02/08 |
| Last modified on | 2013/02/08 18:02:20 |
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Basic information
Public title
Randomized controlled trial to assess the efficacy of the clip with line method during esophageal endoscopic submucosal dissection
Acronym
Randomized controlled trial to assess the efficacy of the clip with line method during esophageal endoscopic submucosal dissection
Scientific Title
Randomized controlled trial to assess the efficacy of the clip with line method during esophageal endoscopic submucosal dissection
Scientific Title:Acronym
Randomized controlled trial to assess the efficacy of the clip with line method during esophageal endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
superficial esophageal carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare treatment time in patients receiving clip with line method versus non clip with line method during esopageal ESD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ESD peeling time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
clip with line method or non clip with line method
Interventions/Control_2
treatment time
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 with superficial esophageal carcinoma terated by ESD
Key exclusion criteria
inability to provide informed consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Koike |
Organization
Sendai City Medical Center
Division name
Depatment of Gastroenterology
Zip code
Address
5-22-1, Trugaya, Miyagino-ku, Sendai 98-0824, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Sendai City Medical Center
Division name
Depatment of Gastroenterology
Zip code
Address
5-22-1, Trugaya, Miyagino-ku, Sendai 98-0824, Japan
TEL
Homepage URL
Sponsor or person
Institute
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
| 2013 | Year | 02 | Month | 08 | 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
| 2012 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 08 | 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
| 2013 | Year | 02 | Month | 08 | Day |
Last modified on
| 2013 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011710
