UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012447 |
|---|---|
| Receipt number | R000014401 |
| Scientific Title | The feasibility and efficacy of EUS-guided pancreatic duct drainage using the novel pancreatic duct stent |
| Date of disclosure of the study information | 2013/11/29 |
| Last modified on | 2014/12/29 09:39:04 |
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Basic information
Public title
The feasibility and efficacy of EUS-guided pancreatic duct drainage using the novel pancreatic duct stent
Acronym
Efficacy of EUS-PD using the novel pancreatic stent
Scientific Title
The feasibility and efficacy of EUS-guided pancreatic duct drainage using the novel pancreatic duct stent
Scientific Title:Acronym
Efficacy of EUS-PD using the novel pancreatic stent
Region
| Japan |
Condition
Condition
Patients in whom EUS-guided PD drainage are needed and difficult ERCP cases.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the feasibility and safety of the novel stent in EUS-guided pancreatic duct drainage.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of EUS-guided pancreatic duct drainage
Key secondary outcomes
Frequency and kinds of complications and stent patency
Base
Study type
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 | Maneuver |
Interventions/Control_1
Endoscopic ultrasonography-guided pancreatic duct 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients in whom EUS-guided PD drainage are needed.
2) Patients consent to be included in the study based on his/her own free will after sufficient informing and understanding of the study.
Key exclusion criteria
1) Cases having difficulty in endoscopic approach
2) Cases in Performance status 4
3) Cases with sever complication in other organs
4) Cases without informed consent
5) Cases judged by principal investigator to be inadequate as subjects
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Itoi |
Organization
Tokyo Medical University Hospital
Division name
Department of the 4th Internal medicine (Gastroenterology and Hepatology)
Zip code
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
itoi@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Itoi |
Organization
Tokyo Medical University Hospital
Division name
Department of the 4th Internal medicine (Gastroenterology and Hepatology)
Zip code
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
itoi@tokyo-med.ac.jp
Sponsor or person
Institute
Department of the 4th Internal medicine, Tokyo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of the 4th Internal medicine, Tokyo Medical University Hospital
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
東京医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 29 | 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 | 11 | Month | 29 | Day |
Last modified on
| 2014 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014401
