UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002492 |
|---|---|
| Receipt number | R000002956 |
| Scientific Title | Safety and Efficacy of a modified small-caliber-tip transparent hood in endoscopic decompression for obstructive colorectal cancer |
| Date of disclosure of the study information | 2009/09/14 |
| Last modified on | 2011/03/22 18:11:23 |
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Basic information
Public title
Safety and Efficacy of a modified small-caliber-tip transparent hood in endoscopic decompression for obstructive colorectal cancer
Acronym
Safety and Efficacy of a modified ST hood in endoscopic decompression for obstructive colorectal cancer
Scientific Title
Safety and Efficacy of a modified small-caliber-tip transparent hood in endoscopic decompression for obstructive colorectal cancer
Scientific Title:Acronym
Safety and Efficacy of a modified ST hood in endoscopic decompression for obstructive colorectal cancer
Region
| Japan |
Condition
Condition
Obstructive left-sided colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic decompression for obstructive colorectal cancer may become easier and more successful by using modified small-caliber-tip transparent hood than by using conventional hood. Comparison on success rate and procedure time in endoscopic decompression for obstructive colorectal cancer between conventional hood and modified ST hood.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate and procedure time to pass the guide-wire through the colorectal stricture site.
Key secondary outcomes
Safety of endoscopic decompression by using modified small-caliber-tip transparent hood.
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
| Device,equipment |
Interventions/Control_1
Endoscopic decompression using modified ST hood (Replaced with conventional hood only if failure occurs with modified ST hood within a specified time).
Interventions/Control_2
Endoscopic decompression using conventional hood (Replaced with modified ST hood only if failure occurs with conventional hood within a specified 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with colorectal obstruction caused by advanced cancer in the left colon.
Key exclusion criteria
Patients who are under age or patients who informed consent cannot be obtained in person or from the surrogate.
Patients who are not candidates for colonoscopy because of concomitant severe infectious disease or underlying severe diseases such as respiratory, circulatory diseases, and etc.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiko Miyata |
Organization
Jichi Medical University, Department of Medicine, Division of Gastroenterology and Hepatology
Division name
Endoscopy Center
Zip code
Address
3311-1 Yakushiji Shimotsuke-shi, Tochigi-ken 329-0498
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Jichi Medical University, Department of Medicine, Division of Gastroenterology and Hepatology
Division name
Endoscopy center
Zip code
Address
TEL
0285-58-7539
Homepage URL
Sponsor or person
Institute
Jichi Medical University, Department of Medicine, Division of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University, Department of Endoscopic Research and International Education (Funded by Fujifilm)
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
| 2009 | Year | 09 | Month | 14 | 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
| 2009 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 14 | Day |
Last modified on
| 2011 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002956
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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