UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018352 |
|---|---|
| Receipt number | R000021246 |
| Scientific Title | Electrocautery vs non-electrocautery dilator catheter of endoscopic ultrasonography (EUS)-guided pancreatic fluid collections drainage |
| Date of disclosure of the study information | 2015/07/21 |
| Last modified on | 2015/07/22 14:01:33 |
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Basic information
Public title
Electrocautery vs non-electrocautery dilator catheter of endoscopic ultrasonography (EUS)-guided pancreatic fluid collections drainage
Acronym
EUS-guided drainage using electrocautery dilation catheter
Scientific Title
Electrocautery vs non-electrocautery dilator catheter of endoscopic ultrasonography (EUS)-guided pancreatic fluid collections drainage
Scientific Title:Acronym
EUS-guided drainage using electrocautery dilation catheter
Region
| Japan |
Condition
Condition
Pancreatic and peripancreatic fluid collections
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and utility of electrocautery dilation catheter of EUS-guided pancreatic fluid collections drainage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
technical and clinical success rates of EUS-guided pancreatic fluid collections drainage using an electrocautery dilation catheter
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
infected and/or symptomatic pancreatic and peripancreatic fluid collections
Key exclusion criteria
coagulopathy, the interposition of vascular on the puncture tract, inability to obtain informed consents
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuya Kitamura |
Organization
Showa University School of Medicine
Division name
Division of Gastroenterology, Department of Medicine
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8535
k.kitamura@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuya Kitamura |
Organization
Showa University School of Medicine
Division name
Division of Gastroenterology, Department of Medicine
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8535
Homepage URL
k.kitamura@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School 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
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 | 07 | Month | 21 | 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
| 2015 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Case control study
Electrocautery group:cases from May 2012 to August 2014
Non-electrocautery group:cases from August 2010 to April 2012
Management information
Registered date
| 2015 | Year | 07 | Month | 20 | Day |
Last modified on
| 2015 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021246
