UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009394 |
|---|---|
| Receipt number | R000011035 |
| Scientific Title | The safety and effectiveness of fully covered self-expanding metallic stent for EUS-guided transenteric pancreatic pseudocyst drainage |
| Date of disclosure of the study information | 2012/11/27 |
| Last modified on | 2020/06/04 20:34:48 |
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Basic information
Public title
The safety and effectiveness of fully covered self-expanding metallic stent for EUS-guided transenteric pancreatic pseudocyst drainage
Acronym
Metallic stent for EUS-guided pseudocyst drainage
Scientific Title
The safety and effectiveness of fully covered self-expanding metallic stent for EUS-guided transenteric pancreatic pseudocyst drainage
Scientific Title:Acronym
Metallic stent for EUS-guided pseudocyst drainage
Region
| Japan |
Condition
Condition
pancreatic pseudocyst which is required drainage
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of safety and efficacy of a fully covered metallic stent for enterocystostomy and related procedure in the treatment of pancreatic pseudocyst
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
The rate ofsuccessful placement
Key secondary outcomes
The rate ofcomplication and clinical success
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Placement of metallic stent for transenteric pancreatic pseudocyst drainage
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pancreatic psedocyst which did not respond to convervative treatment.
Pseudocyst which is contact to stomach or duodenum
Informed consent is obtained
Key exclusion criteria
Massive ascites
Multiple organ failure
Pregnancy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Natsuyo Yamamoto |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL
03-3815-5411
natsuyo@tke.att.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Natsuyo Yamamoto |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL
03-3815-5411
Homepage URL
natsuyo@tke.att.ne.jp
Sponsor or person
Institute
Department of Gastroenterology,The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology,The University of Tokyo
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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 27 | 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 | 08 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 25 | Day |
Last modified on
| 2020 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011035
